- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03548935
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)
November 18, 2021 updated by: Novo Nordisk A/S
Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
This study will look at the change in participants' body weight from the start to the end of the study.
The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine.
In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight.
Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance.
Participants will need to take 1 injection once a week.
The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years.
Participants will have 15 clinic visits and 10 phone calls with the study doctor.
Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan.
These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1961
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Caba, Argentina, C1093AAS
- Novo Nordisk Investigational Site
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Ciudad de Buenos Aires, Argentina, C1204AAD
- Novo Nordisk Investigational Site
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Corrientes, Argentina, 3400
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Córdoba, Argentina, X5006IKK
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Santa Rosa, Argentina, 6300
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Boussu, Belgium, 7300
- Novo Nordisk Investigational Site
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Bruxelles, Belgium, 1200
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Edegem, Belgium, 2650
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1797
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Quebec, Canada, G1V 4G2
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Quebec, Canada, G1V 4G5
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Alberta
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Edmonton, Alberta, Canada, T6H 2L4
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British Columbia
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Surrey, British Columbia, Canada, V3Z 2N6
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Ontario
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Hamilton, Ontario, Canada, L8L 5G8
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North York, Ontario, Canada, M2M 4J5
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Toronto, Ontario, Canada, M4P 1P2
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Aarhus N, Denmark, 8200
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Oulu, Finland, 90220
- Novo Nordisk Investigational Site
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University Of Helsinki, Finland, 00014
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Le Coudray, France, 28630
- Novo Nordisk Investigational Site
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Narbonne, France, 11108
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PARIS cedex 13, France, 75651
- Novo Nordisk Investigational Site
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Paris, France, 75908
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Pessac, France, 33600
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Pierre Benite, France, 69310
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Venissieux, France, 69200
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Berlin, Germany, 12627
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Bochum, Germany, 44787
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Essen, Germany, 45136
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Essen, Germany, 45219
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Falkensee, Germany, 14612
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Frankfurt, Germany, 60313
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Giessen, Germany, 35392
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Hamburg, Germany, 22607
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Hohenmölsen, Germany, 06679
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Leipzig, Germany, 04103
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Saint Ingbert-Oberwürzbach, Germany, 66386
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Stuttgart, Germany, 70378
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Wangen, Germany, 88239
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Hyderabad, India, 500 012
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Ludhiana, India, 141001
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
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Secunderabad,, Andhra Pradesh, India, 500003
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Gujarat
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Surat, Gujarat, India, 395002
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Haryana
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Rohtak, Haryana, India, 124001
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Kerala
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Thiruvananthapuram, Kerala, India, 695031
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Maharashtra
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Nagpur, Maharashtra, India, 440003
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Pune, Maharashtra, India, 411021
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Pune, Maharashtra, India, 411004
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New Delhi
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New Dehli, New Delhi, India, 110029
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600116
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West Bengal
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Kolkata, West Bengal, India, 700054
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Chiba-shi, Chiba, Japan, 260-8677
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Suita-shi, Osaka, Japan, 565-0853
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Tokyo, Japan, 103-0027
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Tokyo, Japan, 103-0028
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Tokyo, Japan, 160-0008
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Jalisco
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Guadalajara, Jalisco, Mexico, 44670
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Sonora
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Hermosillo, Sonora, Mexico, 83280
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Yucatan
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Merida, Yucatan, Mexico, 97070
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Gdynia, Poland, 81-338
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Lodz, Poland, 90-242
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Poznan, Poland, 60-589
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Szczecin, Poland, 70-376
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San Juan, Puerto Rico, 00921
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Moscow, Russian Federation, 117036
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Novosibirsk, Russian Federation, 630099
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Novosibirsk, Russian Federation, 630117
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Penza, Russian Federation, 440026
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Saint-Petersburg, Russian Federation, 194358
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Tomsk, Russian Federation, 634041
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Voronezh, Russian Federation, 394018
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Yaroslavl, Russian Federation, 150003
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Taipei, Taiwan, 100
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Bristol, United Kingdom, BS10 5NB
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Cambridge, United Kingdom, CB2 0QQ
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Coventry, United Kingdom, CV2 2DX
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Glasgow, United Kingdom, G31 2ER
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Liverpool, United Kingdom, L9 7AL
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London, United Kingdom, SE1 9RT
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London, United Kingdom, W1T 7HA
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Norwich, United Kingdom, NR4 7UQ
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Rotherham, United Kingdom, S65 1DA
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Taunton, United Kingdom, TA1 5DA
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Alabama
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Anniston, Alabama, United States, 36207
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California
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Anaheim, California, United States, 92801
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Lomita, California, United States, 90717
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Spring Valley, California, United States, 91978
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Colorado
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Aurora, Colorado, United States, 80045
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Connecticut
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Waterbury, Connecticut, United States, 06708
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Florida
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Chiefland, Florida, United States, 32626
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Crystal River, Florida, United States, 34429
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Jacksonville, Florida, United States, 32216
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32205
- Novo Nordisk Investigational Site
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Ocala, Florida, United States, 34470
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Panama City, Florida, United States, 32401
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Plantation, Florida, United States, 33324
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Ponte Vedra, Florida, United States, 32081
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Georgia
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Roswell, Georgia, United States, 30076
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Illinois
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60611
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Indiana
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Indianapolis, Indiana, United States, 46260
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Kansas
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Topeka, Kansas, United States, 66606
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Kentucky
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Louisville, Kentucky, United States, 40213
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Michigan
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Buckley, Michigan, United States, 49620
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Missouri
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Saint Peters, Missouri, United States, 63303
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Montana
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Butte, Montana, United States, 59701
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Nebraska
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Omaha, Nebraska, United States, 68105
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New York
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Rochester, New York, United States, 14609
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North Carolina
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Salisbury, North Carolina, United States, 28144
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Wilmington, North Carolina, United States, 28401
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Pennsylvania
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West Reading, Pennsylvania, United States, 19611
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South Carolina
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Charleston, South Carolina, United States, 29425
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Simpsonville, South Carolina, United States, 29681
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Tennessee
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Nashville, Tennessee, United States, 37212-1150
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Texas
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Austin, Texas, United States, 78749
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75226
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75234
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Round Rock, Texas, United States, 78681
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Utah
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Bountiful, Utah, United States, 84010
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Virginia
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Richmond, Virginia, United States, 23294
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Washington
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Renton, Washington, United States, 98057
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Main phase:
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Extension phase:
- Informed consent for the extension phase obtained before any trial related activities for the extension phase
- On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo
Exclusion Criteria:
Main phase:
- Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Extension phase:
- Female who is pregnant or intends to become pregnant during the extension phase
- Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Semaglutide s.c. 2.4 mg once weekly
Participants will receive semaglutide for 68 weeks.
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Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.
Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.
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Placebo Comparator: Semaglutide placebo
Participants will receive semaglutide matching placebo for 68 weeks.
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Participants will receive semaglutide matching placebo s.c.
injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Body Weight (%)
Time Frame: Baseline (week 0) to week 68
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Change in body weight from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods.
In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
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Baseline (week 0) to week 68
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Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)
Time Frame: After week 68
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Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are presented.
The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 2 weeks of follow-up.
It excludes any period of temporary treatment interruption.
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After week 68
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Serious Adverse Events (SAEs)
Time Frame: Baseline (week 0) to week 75
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A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
The SAEs occurred from week 0 to week 75 is presented.
The endpoint was evaluated based on the data from on-treatment observation period.
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
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Baseline (week 0) to week 75
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Change in Pulse
Time Frame: Baseline (week 0) to week 68
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Change in pulse from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from on-treatment observation period.
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
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Baseline (week 0) to week 68
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Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)
Time Frame: Week 68
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Number of participants who achieved weight loss more than or equal to (≥) 10% at week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from date of randomization (week 0) to date of last contact with trial site (week 75).
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Week 68
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Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)
Time Frame: Week 68
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Number of participants who achieved more than or equal to (≥) 15% weight loss at week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Week 68
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Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)
Time Frame: Week 68
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Number of participants who achieved more than or equal to (≥) 20% weight loss at week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Week 68
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Change in Waist Circumference (cm)
Time Frame: Baseline (week 0) to week 68
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Change in waist circumference from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).
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Baseline (week 0) to week 68
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Change in Systolic Blood Pressure (mmHg)
Time Frame: Baseline (week 0) to week 68
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Change in systolic blood pressure from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to date of last contact with trial site (week 75).
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Baseline (week 0) to week 68
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Change in Short Form 36 (SF-36)
Time Frame: Baseline (week 0) to week 68
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SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL).
SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary).
In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation, respectively, for the 2009 US general population.
Change from week 0 in the domain scores and component summary scores were evaluated at week 68.
A positive change score indicates an improvement since baseline.
These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score
Time Frame: Baseline (week 0) to week 68
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IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life.
It is used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
The scores range between 0-100 where higher scores indicate a better quality of life.
A positive change score indicates an improvement since baseline.
These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Body Weight (kg)
Time Frame: Baseline (week 0) to week 68
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Change in body weight from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Body Mass Index (BMI) (kg/m2)
Time Frame: Baseline (week 0) to week 68
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Change in body mass index from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in HbA1C (%)
Time Frame: Baseline (week 0) to week 68
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Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in HbA1C (mmol/Mol)
Time Frame: Baseline (week 0) to week 68
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Change in HbA1c from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Fasting Plasma Glucose (FPG) (mg/dL)
Time Frame: Baseline (week 0) to week 68
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Change in fasting plasma glucose from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
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Change in fasting serum insulin from week 0 to week 68 is presented as ratio to baseline.
Fasting serum insulin was measured in milli-international units per milliliter (mIU/mL).
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Diastolic Blood Pressure (mmHg)
Time Frame: Baseline (week 0) to week 68
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Change in diastolic blood pressure from baseline (week 0) to week 68 is presented.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Total Cholesterol (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
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Change in fasting total cholesterol from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
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Change in fasting HDL from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
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Change in fasting LDL from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
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Change in fasting VLDL from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
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Baseline (week 0) to week 68
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Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
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Change in fasting free fatty acids from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Triglycerides (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in fasting triglycerides from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in high sensitivity C-reactive protein from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in plasminogen activator inhibitor-1 activity from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in soluble leptin receptor from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Leptin (ng/mL) - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in leptin from baseline (week 0) to week 68 is presented as ratio to baseline.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Composition (Total Fat Mass) (%)
Time Frame: Baseline (week 0) to week 68
|
Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented.
Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA).
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Composition (Total Fat Mass) (kg)
Time Frame: Baseline (week 0) to week 68
|
Change in body composition (total fat mass) from baseline (week 0) to week 68 is presented.
Body composition was assessed using Dual Energy X-ray Absorpmetry (DEXA).
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Composition (Lean Body Mass) (%)
Time Frame: Baseline (week 0) to week 68
|
Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented.
Body composition was assessed using DEXA.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Composition (Lean Body Mass) (kg)
Time Frame: Baseline (week 0) to week 68
|
Change in body composition (lean body mass) from baseline (week 0) to week 68 is presented.
Body composition was assessed using DEXA.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Composition (Visceral Fat Mass) (%)
Time Frame: Baseline (week 0) to week 68
|
Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented.
Body composition was assessed using DEXA.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Composition (Visceral Fat Mass) (kg)
Time Frame: Baseline (week 0) to week 68
|
Change in body composition (visceral fat mass) from baseline (week 0) to week 68 is presented.
Body composition was assessed using DEXA.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Weight (%) - DEXA Subpopulation
Time Frame: Baseline (week 0) to week 68
|
Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Change in Body Weight (kg) - DEXA Subpopulation
Time Frame: Baseline (week 0) to week 68
|
Change in body weight from baseline (week 0) to week 68 is presented in DEXA subpopulation.
The endpoint was evaluated based on the data from in-trial observation period.
In-trial observation period: the uninterrupted time interval from start of randomization (week 0) to last trial-related subject-site contact (week 75).
|
Baseline (week 0) to week 68
|
Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score
Time Frame: After week 68
|
The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two different thresholds.
The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population.
The threshold of 3.7 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations.
In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold.
The endpoint was evaluated based on the in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
|
After week 68
|
Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score
Time Frame: After week 68
|
The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds.
The threshold of 20 was a preliminary responder threshold based on earlier studies.
The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations.
In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold.
The endpoint was evaluated based on the in-trial observation period.
In trial observation period: the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75).
|
After week 68
|
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline (week 0) to week 75
|
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product.
All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event for which the onset of the event occurs in the on-treatment period.
The endpoint was evaluated based on the data from on-treatment observation period.
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
|
Baseline (week 0) to week 75
|
Change in Amylase - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in amylase (measured as units per litre [U/L]) is presented as ratio to baseline.
The endpoint was evaluated based on the data from on-treatment observation period.
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
|
Baseline (week 0) to week 68
|
Change in Lipase - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in lipase (measured as units per litre [U/L]) is presented as ratio to baseline.
The endpoint was evaluated based on the data from on-treatment observation period.
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
|
Baseline (week 0) to week 68
|
Change in Calcitonin - Ratio to Baseline
Time Frame: Baseline (week 0) to week 68
|
Change in calcitonin (measured as ng/L) is presented as ratio to baseline.
The endpoint was evaluated based on the data from on-treatment observation period.
On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up.
It excludes any period of temporary treatment interruption.
Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
|
Baseline (week 0) to week 68
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
- Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.
- O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
- Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2022 Oct 6. doi: 10.1111/dom.14890. Online ahead of print.
- Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2018
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
March 5, 2021
Study Registration Dates
First Submitted
May 25, 2018
First Submitted That Met QC Criteria
May 25, 2018
First Posted (Actual)
June 7, 2018
Study Record Updates
Last Update Posted (Actual)
November 19, 2021
Last Update Submitted That Met QC Criteria
November 18, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9536-4373
- U1111-1200-8053 (Other Identifier: World Health Organization (WHO))
- 2017-003436-36 (Registry Identifier: European Medicines Agency (EudraCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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