A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CagriSema (Cagrilintide B and Semaglutide I) — DRUG
  CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
• Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) — DRUG
  Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Study Details

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.

Key Dates

Start date

Jun 3, 2025

Status verified

Dec 2025

Primary completion

Mar 1, 2027

Completion

Oct 17, 2028

Study Design

Enrollment

609 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to week 80 ]

Locations (46)

Find similar trials in Costa Mesa, CA

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