A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
Purpose
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
Conditions
- Overweight
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. - Male or female (sex assigned at birth, inclusive of all gender identities). - Age 18 years or above at the time of signing the informed consent. - Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m^2), or BMI >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
Exclusion Criteria
- History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D). - Previous dosing of marketed or non-marketed amylin-based compounds. - Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2 |
Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks. |
|
|
Experimental Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 |
Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
|
|
Placebo Comparator Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 |
Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
|
Recruiting Locations
Hope Clin Res & Wellness
Conyers, Georgia 30094
Conyers, Georgia 30094
East West Med Res Inst
Honolulu, Hawaii 96814
Honolulu, Hawaii 96814
Midwest Inst For Clin Res
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
The Alliance for Multispecialty Research LLC AMR
Lexington, Kentucky 40509
Lexington, Kentucky 40509
PharmQuest
Greensboro, North Carolina 27408
Greensboro, North Carolina 27408
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Coastal Carolina Res Ctr
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Health Res of Hampton Roads
Newport News, Virginia 23606
Newport News, Virginia 23606
National Clin Res Inc.
Richmond, Virginia 23294
Richmond, Virginia 23294
Selma Medical Associates
Winchester, Virginia 22601-3834
Winchester, Virginia 22601-3834
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S