A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Purpose
This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female (sex at birth). - Age 18 years or above at the time of signing the informed consent. - BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening. - Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.
Exclusion Criteria
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening. - History of type 1 or type 2 diabetes.
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
- Participants in the main phase will be randomised in double blinded manner to receive either CagriSema or matching placebo. In the extension phase, eligible participants will be re-randomised and enter the open label extension phase. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CagriSema |
Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks. |
|
Recruiting Locations
More Details
- NCT ID
- NCT07011667
- Status
- Active, not recruiting
- Sponsor
- Novo Nordisk A/S