- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649137
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
April 24, 2026 updated by: Novo Nordisk A/S
Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study.
The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide.
In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active.
Participants will either get semaglutide or "dummy" medicine.
Which treatment participants get is decided by chance.
Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine.
The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms.
After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose.
The study will last for about 1.5 years
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
512
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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Blagoevgrad, Bulgaria, 2700
- MHAT - Blagoevgrad AD, Department of Internal Diseases
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Burgas, Bulgaria, 8000
- IPSOMC - Dr. Georgi Marinov
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Dobrich, Bulgaria, 9300
- Medical Center Viva Feniks OOD
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Pazardzhik, Bulgaria, 4400
- UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
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Plovdiv, Bulgaria, 4004
- MHAT Sveta Karidad EAD
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Sliven, Bulgaria, 8800
- MHAT Hadzhi Dimitar OOD
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Sofia, Bulgaria, 1233
- DCC VII - Sofia EOOD, Endocrinology
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Stara Zagora, Bulgaria, 6003
- UMHAT Prof. Dr. Stoyan Kirkovich AD
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Yambol, Bulgaria, 8600
- MHAT Sveti Panteleimon - Yambol AD
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British Columbia
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Surrey, British Columbia, Canada, V3Z 2N6
- Ocean West Research Clinic
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- G.A. Research Associates Ltd.
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Hlth Halifax
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Ontario
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Hamilton, Ontario, Canada, L8L 5G4
- Premier Clinical Trial Research Network (PCTRN)
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Hamilton, Ontario, Canada, L8L 5G8
- Wharton Medical Clinic Clinical Trials (Hamilton)
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London, Ontario, Canada, N5W 6A2
- Milestone Research
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Budapest, Hungary, 1106
- Bajcsy-Zsilinszky Kórház
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Budapest, Hungary, 1089
- ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
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Budapest, Hungary, 1132
- MED-TIMA Kft.
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Székesfehérvár, Hungary, 8000
- Fejér Megyei Szent György Oktatókórház
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Bács-Kiskun county
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Baja, Bács-Kiskun county, Hungary, 6500
- Lausmed Kft.
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Hungary, 4025
- Belinus Bt.
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Szabolcs-Szatmar Varmegye
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Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary, 4405
- Borbánya Praxis E.Ü. Kft.
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Katowice, Poland, 40-752
- Uniwersyteckie Centrum Kliniczne SUM w Katowicach
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Warsaw, Poland, 00-710
- NBR Polska Tomasz Klodawski
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Warsaw, Poland, 02-507
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Poland, 31-261
- Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
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Lubelski
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Lublin, Lubelski, Poland, 20-538
- NZOZ Przychodnia Specjalistyczna Medica
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Poland, 20-044
- NZOZ "CenterMed Lublin" Sp. z o.o.
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Poland, 15-481
- Kresmed Sp. z o. o.
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Poland, 81-338
- Centrum Medyczne Pratia Gdynia
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Lisbon, Portugal, 1250-230
- APDP - Associação Protectora dos Diabéticos de Portugal
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Lisbon, Portugal, 1349-019
- Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
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Lisbon, Portugal, 1500-650
- Hospital da Luz Lisboa, S.A.
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Porto, Portugal, 4200-319
- ULS De São João, E.P.E. - Hospital de São João
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Vila Nova de Gaia, Portugal, 4400-346
- Hospital da Luz Arrabida, S.A.
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Matosinhos
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Senhora Da Hora, Matosinhos, Matosinhos, Portugal, 4464-513
- ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
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Bardejov, Slovakia, 08501
- DIADA s.r.o.
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Bardejov, Slovakia, 08501
- DIADA, s.r.o.
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Bytča, Slovakia, 014 01
- Diab - Int, s.r.o.
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Košice, Slovakia, 04013
- Endomed, s.r.o.
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Považská Bystrica, Slovakia, 01701
- MED-DIA CENTRUM s.r.o.
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Prešov, Slovakia, 080 01
- DIABETOL, s.r.o.
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Eastern Cape
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Port Elizabeth, Eastern Cape, South Africa, 6001
- Phoenix Pharma
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Free State
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Bloemfontein, Free State, South Africa, 9301
- Medi-Clinic Bloemfontein
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Gauteng
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Johannesburg, Gauteng, South Africa, 1820
- Deepak Lakha
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Johannesburg, Gauteng, South Africa, 1827
- Hemant Makan
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Johannesburg, Gauteng, South Africa, 2013
- Wits Bara Clinical Trial Site
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Johannesburg, Gauteng, South Africa, 1818
- Soweto Clinical Trial Centre
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4001
- Maxwell Centre
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Durban, KwaZulu-Natal, South Africa, 4092
- Precise Clinical Solutions (Pty) Ltd
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Durban, KwaZulu-Natal, South Africa, 4901
- Lenmed Shifa Private Hospital
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Durban, KwaZulu-Natal, South Africa, 4093
- Dr N.K. Gounden Medical Centre
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eMkhomazi, KwaZulu-Natal, South Africa, 4170
- Dr T Padayachee
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Alabama
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Birmingham, Alabama, United States, 35222
- Univ of Alabama Birmingham
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Montgomery, Alabama, United States, 36106
- Chambliss Clinical Trials, LLC
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California
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Concord, California, United States, 94520
- John Muir Physicians Network
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Los Angeles, California, United States, 90057
- Velocity Clinical Research Westlake
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research, Inc.
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Colorado
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Golden, Colorado, United States, 80401
- New West Physicians PC
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Florida
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DeLand, Florida, United States, 32720
- ARS- Deland CRU
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Jacksonville, Florida, United States, 32216
- Jacksonville Ctr For Clin Res
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Orlando, Florida, United States, 32825
- Florida Inst For Clin Res LLC
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Oviedo, Florida, United States, 32765
- Oviedo Medical Research, LLC
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Georgia
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Conyers, Georgia, United States, 30094
- Hope Clin Res & Wellness
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New York
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Albany, New York, United States, 12203
- AMC Community Endocrinology
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina
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Greensboro, North Carolina, United States, 27408
- PharmQuest Life Sciences LLC
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Texas
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Amarillo, Texas, United States, 79106
- Amarillo Med Spec LLP
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Austin, Texas, United States, 78704
- Elligo Clin Res Centre
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Dallas, Texas, United States, 75230
- Velocity Clin Res, Dallas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center - Lingvay
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Houston, Texas, United States, 77079
- PlanIt Research, PLLC
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Longview, Texas, United States, 75605
- DCOL Ctr for Clin Res
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Sugar Land, Texas, United States, 77479
- Sugar Lakes Family Practice PA
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Virginia
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Richmond, Virginia, United States, 23294
- National Clin Res Inc.
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Winchester, Virginia, United States, 22601-3834
- Selma Medical Associates
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
- Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.
Exclusion Criteria:
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
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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Placebo Comparator: Placebo
Participants will receive once-weekly s.c.
injection of placebo matched to semaglutide for 72 weeks.
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Participants will receive once-weekly s.c.
injection of placebo matched to semaglutide for 72 weeks.
Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
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Experimental: Semaglutide 7.2 mg
Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week.
Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.
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Participants will receive once-weekly s.c.
injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week.
Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks.
Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Participants will receive once-weekly s.c.
injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week.
Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks.
Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
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Experimental: Semaglutide 2.4 mg
Participants will receive once-weekly s.c.
injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached.
Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.
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Participants will receive once-weekly s.c.
injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week.
Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks.
Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Participants will receive once-weekly s.c.
injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week.
Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks.
Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relative Change in Body Weight
Time Frame: Baseline (week 0), End of treatment (week 72)
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Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Time Frame: At week 72
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Number of participants who achieve body weight reduction >=5% is presented.
Yes defines participants who achieved body weight reduction >= 5% and No defines participants who did not achieve body weight reduction >=5%.
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At week 72
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)
Time Frame: At week 72
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Number of participants who achieve body weight reduction >=10% is presented.
Yes defines participants who achieved body weight reduction greater than or equal to 10% and No defines participants who did not achieve body weight reduction greater than or equal to 10%.
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At week 72
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Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)
Time Frame: At week 72
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Number of participants who achieve body weight reduction >=15% is presented.
Yes defines participants who achieved body weight reduction greater than or equal to 15% and No defines participants who did not achieve body weight reduction greater than or equal to 15%.
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At week 72
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Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)
Time Frame: At week 72
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Number of participants who achieve body weight reduction >=20% is presented.
Yes defines participants who achieved body weight reduction greater than or equal to 20% and No defines participants who did not achieve body weight reduction greater than or equal to 20%.
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At week 72
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Change in Waist Circumference
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Body Weight
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Body Mass Index (BMI)
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Systolic Blood Pressure
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Diastolic Blood Pressure
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in HDL Cholesterol (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in LDL Cholesterol (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
|
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Change in Triglycerides (mmol/L) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
|
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
|
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Change in Triglycerides (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in free fatty acids in mmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in free fatty acids in mg/dL from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in hsCRP in mg/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
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Baseline (week 0), End of treatment (week 72)
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Change in Fasting Plasma Glucose
Time Frame: Baseline (week 0), End of treatment (week 72)
|
Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.
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Baseline (week 0), End of treatment (week 72)
|
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Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
|
Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
|
Baseline (week 0), End of treatment (week 72)
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Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Time Frame: Baseline (week 0), End of treatment (week 72)
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Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) as ratio to baseline is presented.
|
Baseline (week 0), End of treatment (week 72)
|
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Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])
Time Frame: At week 72
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Number of participants with HbA1c less than 7.0 % (53 mmol/mol) at week 72 is presented.
|
At week 72
|
|
Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)
Time Frame: At week 72
|
Number of participants with HbA1c less than or equal to 6.5% (48 mmol/mol) at week 72 is presented.
|
At week 72
|
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Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Time Frame: At week 81
|
Number of AEs is reported.
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
|
At week 81
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Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Time Frame: At week 81
|
Number of SAEs is reported.
A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
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At week 81
|
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Change in Pulse
Time Frame: Baseline (week 0), End of treatment (week 72)
|
Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.
|
Baseline (week 0), End of treatment (week 72)
|
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Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: At week 81
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Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.
|
At week 81
|
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Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Time Frame: At week 81
|
Number of AEs is reported.
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.
|
At week 81
|
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Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Time Frame: At week 81
|
Number of SAEs is reported.
A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
|
At week 81
|
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Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: At week 81
|
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes is presented.
|
At week 81
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
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.
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)
January 4, 2023
Primary Completion (Actual)
October 28, 2024
Study Completion (Actual)
December 13, 2024
Study Registration Dates
First Submitted
December 5, 2022
First Submitted That Met QC Criteria
December 5, 2022
First Posted (Actual)
December 13, 2022
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 24, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Diabetes Mellitus, Type 2
- Glucagon-Like Peptide-1 Receptor Agonists
- Physiological Effects of Drugs
- Hypoglycemic Agents
- semaglutide
Other Study ID Numbers
- NN9536-7545
- 2022-002235-60 (EudraCT Number)
- U1111-1279-0359 (Other Identifier: World Health Organization (WHO))
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 novonordisktrials.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
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Clinical Trials on Obesity
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Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
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Central Hospital, Nancy, FranceNot yet recruiting
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Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
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Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
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Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
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Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
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Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
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The Hospital for Sick ChildrenCompleted
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Ihuoma EneliCompletedObesity, ChildhoodUnited States
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Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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AkesoNot yet recruitingAtopic DermatitisChina
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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Chong Kun Dang PharmaceuticalUnknownHypertension | DyslipidemiasKorea, Republic of
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States