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A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

NCT06780449 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-01-20

No results posted yet for this study

Summary

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Conditions

Interventions

DRUG

Cagrilintide

Participants will receive cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive semaglutide subcutaneously.

DRUG

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

DRUG

Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2028-08-28
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Portugal
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780449 on ClinicalTrials.gov