Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
Purpose
This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.
Conditions
- Obesity
- Overweight
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 - Female or male (sex at birth) - Age 18 years or above at the time of signing the informed consent - History of at least one self-reported unsuccessful dietary effort to lose body weight (a*) - Body mass index (BMI) greater than or equal to >= 30.0 kilogram per square meter (kg/m^2), or BMI greater than or equal to >= 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 (a*)
Exclusion Criteria
- History of type 1 or type 2 diabetes (a*) - Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a*) - Previous dosing of marketed or non-marketed amylin-based compounds (a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
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 |
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks. |
|
Recruiting Locations
Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921 94598
Walnut Creek 5406990, California 5332921 94598
Univ of Colorado at Denver
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Florida Inst For Clin Res LLC
Orlando 4167147, Florida 4155751 32825
Orlando 4167147, Florida 4155751 32825
Oviedo Medical Research, LLC
Oviedo 4167348, Florida 4155751 32765
Oviedo 4167348, Florida 4155751 32765
Walgreens - Store 11760
Oak Park 4904381, Illinois 4896861 60302
Oak Park 4904381, Illinois 4896861 60302
Midwest Inst For Clin Res
Indianapolis 4259418, Indiana 4921868 46260
Indianapolis 4259418, Indiana 4921868 46260
StudyMetrix Research LLC
City of Saint Peters 4407237, Missouri 4398678 63303
City of Saint Peters 4407237, Missouri 4398678 63303
PharmQuest Life Sciences LLC
Greensboro 4469146, North Carolina 4482348 27408
Greensboro 4469146, North Carolina 4482348 27408
Selma Medical Associates
Winchester 4794120, Virginia 6254928 22601-3834
Winchester 4794120, Virginia 6254928 22601-3834
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S