A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (REDEFINE 2)

April 18, 2024 updated by: Novo Nordisk A/S

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1200

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 Contact

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Innere Medizin
      • Saint Stefan, Austria, 8511
        • Fließer-Görzer [Ordination]
      • Wien, Austria, 1090
        • Universitätsklinikum AKH Wien
      • Wien, Austria, 1030
        • Klinik Landstraße
      • Wien, Austria, A 1190
        • Imed 19- privat
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • LMC Clin Res Inc. Calgary
      • Calgary, Alberta, Canada, T2V 4J2
        • C-endo Diab Endo Clin Calgery
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 4A1
        • Dr. M.B. Jones Inc
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Commonwealth Medical Clinic
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Dr. Harpreet Bajaj
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Centricity Research Etobicoke
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Med Clin Trials
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research
      • Nepean, Ontario, Canada, K2J 0V2
        • LMC Research Inc. Ottawa
      • Toronto, Ontario, Canada, M6G 1M2
        • Diabetes Heart Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H4N 2W2
        • Centre Medical Acadie
      • Pointe-Claire, Quebec, Canada, H9R 4S5
        • Centricity Res Pointe-Claire
      • Saint-Laurent, Quebec, Canada, H4T 1Z9
        • LMC Clin Rsrch Inc. (Montreal)
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Diabetespraxis Mergentheim
      • Elsterwerda, Germany, 04910
        • Zentrum fuer klinische Studien Suedbrandenburg GmbH
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Hamburg, Germany, 22607
        • Wendisch/Dahl Hamburg
      • Leipzig, Germany, 04107
        • AmBeNet GmbH
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Zentrum für klinische Studien Alexander Segner
      • Stuttgart, Germany, 70378
        • Erlinger
      • Wangen, Germany, 88239
        • Zentrum für klinische Studien Allgäu Oberschwaben
  • Hungary
      • Budapest, Hungary, 1106
        • Bajcsy-Zsilinszky Kórház
      • Budapest, Hungary, 1042
        • Szőcs Depot Egészségügyi Szolgáltató Kft.
      • Budapest, Hungary, 1036
        • Clinexpert Egeszsegugyi Szolgaltato Es Kereskedelmi Kft.
      • Komárom, Hungary, 2900
        • Selye János Kórház és Rendelőintézet
      • Szolnok, Hungary, 5004
        • Hetényi Géza Kórház
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, H-6725
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Belgyógyászati Klinika
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
        • Hetényi Géza Kórház
    • Komárom-Esztergom
      • Komárom, Komárom-Esztergom, Hungary, 2900
        • Selye János Kórház és Rendelőintézet
  • India
      • Nagpur, India, 440010
        • Sunil's Diabetes Care n' Research Centre Pvt Ltd
      • New Delhi, India, 110001
        • Lady Hardinge Medical College
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • HCG Hospitals
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Ramaiah Memorial Hospital
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Calicut Medical College
      • Thiruvananthapuram, Kerala, India, 695031
        • Indian Institute of Diabetes
    • Maharashtra
      • Kolhapur, Maharashtra, India, 416008
        • Excel Endocrine Centre
      • Mumbai, Maharashtra, India, 400012
        • Seth GS medical college and KEM Hospital
      • Mumbai, Maharashtra, India, 400008
        • BYL Nair Hospital and T N Medical College Department of endo
      • Nagpur, Maharashtra, India, 440010
        • Sunil's Diabetes Care n' Research Centre Pvt Ltd
      • Pune, Maharashtra, India, 411013
        • Noble Hospitals Pvt Ltd.
    • New Delhi
      • Ansari Nagar, New Delhi, India, 110029
        • All India Institute of Medical Sciences_Delhi
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Post Graduate Institute of Medical Education & Research_Chandigarh
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Medical College & Hospital
      • Jaipur, Rajasthan, India, 302004
        • J K Lon Hospital, SMS Medical College & Attached Hospitals
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
      • Chennai, Tamil Nadu, India, 600006
        • Apollo Research & Innovation (ARI)
    • Telangana
      • Hyderabad, Telangana, India, 500004
        • Gleneagles Global Hospitals
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Multispeciality Hospital, Kolkata
      • Kolkata, West Bengal, India, 700054
        • Apollo Multispeciality Hospitals Limited
  • Ireland
    • Connaght
      • Galway, Connaght, Ireland, H91 YR71
        • CRF - Galway
    • Leinster
      • Dublin, Leinster, Ireland, D04 T6F4
        • Clinical Research Centre, St. Vincent's University Hospital,
      • Dublin, Leinster, Ireland, D07 XAO9
        • Mater Miscericordiae Hospital
      • Dublin, Leinster, Ireland, D08 A978
        • St James's CRF
      • Dublin, Leinster, Ireland, DUBLIN 15
        • Connolly Hospital
      • Dublin, Leinster, Ireland, DUBLIN 7
        • Mater Miscericordiae Hospital
  • Japan
      • Aichi, Japan, 468-0009
        • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
      • Chiba, Japan, 261-0004
        • Tokuyama clinic
      • Ibaraki, Japan, 311-0113
        • Naka Kinen Clinic
      • Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Osaka, Japan, 530-0001
        • AMC NISHI-UMEDA Clinic_Diabetes Internal Medicine
      • Osaka, Japan, 569-1045
        • Takatsuki Red Cross Hospital
  • Malaysia
      • Melaka, Malaysia, 75400
        • Hospital Melaka
      • Seremban, Malaysia, 70300
        • Hospital Tuanku Jaafar
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Hospital Universiti Kebangsaan Malaysia
    • Miri
      • Sarawak, Miri, Malaysia, 98000
        • Hospital Miri
    • Perak
      • Seri Manjung, Perak, Malaysia, 32040
        • Hospital Seri Manjung
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital
    • Selangor
      • Ampang, Selangor, Selangor, Malaysia, 68000
        • Hospital Ampang
      • Sungai Buloh, Selangor, Malaysia, 47000
        • University Technology MARA (UiTM) - Puncak Alam
    • Wilayah Persekutuan Putrajaya
      • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
        • Hospital Putrajaya
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bygdoszcz, Poland, 85-796
        • Gierach-Med
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Kraków, Poland, 30-721
        • Linden sp. z o.o. sp. k.
      • Lublin, Poland, 20-333
        • Terpa Sp. z o.o. Sp. k.
    • Dolnośląskie
      • Legnica, Dolnośląskie, Poland, 59-220
        • Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
    • Kuyavian-Pomeranian Voivodeship
      • Bygdoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Gierach-Med
    • Lubelskie Voivodeship
      • Lublin, Lubelskie Voivodeship, Poland, 20-333
        • Terpa Sp. z o.o. Sp. k.
    • Mazovian
      • Warszawa, Mazovian, Poland, 02-117
        • Instytut Diabetologii Sp. z o.o.
    • Mazovian Voivodeship
      • Warszawa, Mazovian Voivodeship, Poland, 02-117
        • Instytut Diabetologii Sp. z o.o.
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-416
        • Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
      • Warszawa, Mazowieckie, Poland, 02-798
        • Medical Concierge Centrum Medyczne
    • Małopolskie
      • Kraków, Małopolskie, Poland, 30-721
        • Linden sp. z o.o. sp. k.
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-281
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bialystok, Podlaskie Voivodeship, Poland, 15-281
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
    • Slaskie Voivodeship
      • Katowice, Slaskie Voivodeship, Poland, 40-772
        • Centrum Medyczne Salvia
    • Warmińsko-Mazurskie
      • Elblag, Warmińsko-Mazurskie, Poland, 82-300
        • Klinika Bellamed
    • Wielkopolskie Voivodeship
      • Poznan, Wielkopolskie Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego
    • Łódzkie
      • Piotrków Trybunalski, Łódzkie, Poland, 97-300
        • Trialmed CRS
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Med School Found Inc
  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital_Bangkok
    • Bangkok
      • Bangkoknoi, Bangkok, Bangkok, Thailand, 10700
        • Siriraj Hospital_Bangkoknoi, Bangkok
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
    • Pathumthani
      • Klong Luang, Pathumthani, Pathumthani, Thailand, 12120
        • Thammasat University Hospital
  • United Kingdom
      • Antrim, United Kingdom, BT42 2RL
        • Antrim Area Hospital
      • Blackpool, United Kingdom, FY3 7EN
        • Layton Medical Centre
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • The Health Centre
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Chippenham, United Kingdom, SN14 6GT
        • Hathaway Medical Centre
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Harrogate District Hospital
      • Hounslow,, United Kingdom, TW5 9ER
        • HMC Health Heston
      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • Nantwich, United Kingdom, CW5 5NX
        • Kiltearn Medical Centre
      • Rotherham, United Kingdom, S651DA
        • Clifton Medical centre
      • Sandbach, United Kingdom, CW11 1EQ
        • Ashfields Primary Care Centre
      • Soham, United Kingdom, CB7 5JD
        • The Staploe Medical Centre
      • Swansea, United Kingdom, SA2 8PP
        • Joint Clinical Research Facility - Swansea
      • Taunton, United Kingdom, TA1 5DA
        • Musgrove Park Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital (Treliske)
      • Wellingborough, United Kingdom, NN8 4RW
        • Albany House Medical Centre
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • Crouch Oak Family Practice
  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network
      • Escondido, California, United States, 92025
        • AMCR Institute Inc
      • Escondido, California, United States, 92025
        • Headlands Research California, LLC
      • Fullerton, California, United States, 92835
        • St. Jos Heritage Hlthcr_Fllrtn
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Mgmt & Res Ctr
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Los Angeles, California, United States, 90057
        • Velocity Clin Res Wstlke
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Colorado
      • Golden, Colorado, United States, 80401
        • New West Physicians,Inc.
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Res Of W Florida Inc
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Ctr for Clin Res
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Orlando, Florida, United States, 32825
        • Florida Institute For Clinical Research, LLC
      • Orlando, Florida, United States, 32804
        • AdventHealth Diab Inst
      • Oviedo, Florida, United States, 32765
        • Oviedo Medical Research, LLC
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endo Res Solutions Inc
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, United States, 66606-2806
        • Cotton-Oneill Diabetes and End
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biom Res Ctr
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Hlth Ctr, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research LLC
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Str Med Grp, PLLC
    • New York
      • Albany, New York, United States, 12203
        • Albany Medical College - Endo
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681-1538
        • Hillcrest Clinical Research
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Med Spec LLP
      • Austin, Texas, United States, 78731
        • Texas Diab & Endo, P.A.
      • Austin, Texas, United States, 78749
        • Texas Diab & Endo, P.A.
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Utah
      • Saint George, Utah, United States, 84790
        • Chrysalis Clinical Research
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clin Res Inc.
      • Winchester, Virginia, United States, 22601
        • Amherst Family Practice P.C.
      • Winchester, Virginia, United States, 22601-3834
        • Selma Medical Associates
    • Washington
      • Olympia, Washington, United States, 98502
        • Capital Clin Res Ctr,LLC

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 greather than or equal to 27.0 kg/m^2
  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
  • HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Exclusion Criteria:

  • Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
  • Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured 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 randomisation. 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
Experimental: CagriSema
Cagrilintide + semaglutide once weekly
Drug: Cagrilintide
Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
Drug: Semaglutide
Semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Placebo Comparator: Placebo
Placebo cagrilintide + semaglutide once weekly
Drug: Placebo cagrilintide
Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
Drug: Placebo semaglutide
Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
From baseline (week 0) to end of treatment (week 68)
Achievement of greater than or equal to (≥) 5% weight reduction
Time Frame: From baseline (week 0) to end of treatment (week 68)
Count of participant.
From baseline (week 0) to end of treatment (week 68)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of ≥ 20% weight reduction
Time Frame: From baseline (week 0) to end of treatment (week 68)
Count of participant.
From baseline (week 0) to end of treatment (week 68)
Relative change in body weight
Time Frame: From baseline (week 0) to week 20
Measured in %.
From baseline (week 0) to week 20
Change in waist circumference
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
From baseline (week 0) to end of treatment (week 68)
Change in Glycated Haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
From baseline (week 0) to end of treatment (week 68)
Change in Systolic Blood Pressure (SBP)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in millimeter of mercury (mmHg).
From baseline (week 0) to end of treatment (week 68)
Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in score points.
From baseline (week 0) to end of treatment (week 68)
Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in score points.
From baseline (week 0) to end of treatment (week 68)
Change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in kilogram (kg).
From baseline (week 0) to end of treatment (week 68)
Change in body mass index (BMI)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in kilogram per meter square (kg/m^2).
From baseline (week 0) to end of treatment (week 68)
Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Count of participant.
From baseline (week 0) to end of treatment (week 68)
Achievement of HbA1c less than or equal to (≤) 6.5%
Time Frame: At end of treatment (week 68)
Count of participant.
At end of treatment (week 68)
Change in Fasting Plasma Glucose (mmol/L)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in millimoles per liter (mmol/L).
From baseline (week 0) to end of treatment (week 68)
Change in Fasting Plasma Glucose (mg/dL)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in milligram per deciliter (mg/dL)
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in fasting serum insulin
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Change in Diastolic Blood Pressure (DBP)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in mmHg.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in C-reactive protein (CRP)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score
Time Frame: From baseline (week 0) to end of treatment (week 68)
IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning.
From baseline (week 0) to end of treatment (week 68)
Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score
Time Frame: From baseline (week 0) to end of treatment (week 68)
CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control.
From baseline (week 0) to end of treatment (week 68)
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
Time Frame: From baseline (week 0) to end of treatment (week 68)
Count of participant.
From baseline (week 0) to end of treatment (week 68)
Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score
Time Frame: From baseline (week 0) to end of treatment (week 68)
Count of participant.
From baseline (week 0) to end of treatment (week 68)
Change in IWQOL-Lite-CT Physical Function score
Time Frame: From baseline (week 0) to end of treatment (week 68)
From baseline (week 0) to end of treatment (week 68)
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup
Time Frame: From baseline (week 0) to end of treatment (week 68)
Count of participant.
From baseline (week 0) to end of treatment (week 68)
Continuous glucose monitoring: Change in mean glucose (mmol/L)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in mmol/L.
From baseline (week 0) to end of treatment (week 68)
Continuous glucose monitoring: Change in mean glucose (mg/L)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in mg/L.
From baseline (week 0) to end of treatment (week 68)
CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
From baseline (week 0) to end of treatment (week 68)
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
From baseline (week 0) to end of treatment (week 68)
CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
From baseline (week 0) to end of treatment (week 68)
CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
From baseline (week 0) to end of treatment (week 68)
CGM: Within-day glycaemic variability (% CV)
Time Frame: At end of treatment (week 68)
Measured in %.
At end of treatment (week 68)
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: From baseline (week 0) to end of study (week 75)
Count of events.
From baseline (week 0) to end of study (week 75)
Number of Treatment Emergent Serious adverse events (TESAEs)
Time Frame: From baseline (week 0) to end of study (week 75)
Count of events.
From baseline (week 0) to end of study (week 75)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Time Frame: From baseline (week 0) to end of study (week 75)
Count of episodes.
From baseline (week 0) to end of study (week 75)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Time Frame: From baseline (week 0) to end of study (week 75)
Count of episodes.
From baseline (week 0) to end of study (week 75)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

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)

February 1, 2023

Primary Completion (Estimated)

December 11, 2024

Study Completion (Estimated)

January 29, 2025

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9838-4609
  • U1111-1267-4287 (Other Identifier: World Health Organization (WHO))
  • 2021-005121-24 (EudraCT Number)
  • jRCT2031220671 (Registry Identifier: jRCT (Japan))

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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