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

NCTNCT06780449Other idNN9838-7859Other idU1111-1304-7430Other id2024-512144-39

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 400 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 6 countries
United States, Belgium, Canada, Denmark, Portugal, United Kingdom
Start: 10 Feb 2025
Primary completion: 28 Aug 2028 (estimated)
Completion: 31 Oct 2028 (estimated)
First posted: 17 Jan 2025
Last update posted: 20 Jan 2026
Conditions: Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026202720282029

Ph 3
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
NCT06780449
10 Feb 2025 to est. 31 Oct 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CagrilintideDrug
SemaglutideDrug
Placebo cagrilintideDrug
Placebo semaglutideDrug

Arms2

Experimental
CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.
Placebo comparator
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to week 104
Registry description
Measured in percentage (%).

Secondary outcomes(20)

Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
Time frame · From baseline (week 0) to week 104
Registry description
Measured as count of participants.
Number of participants who achieve >= 25 percent body weight reduction
Time frame · From baseline (week 0) to week 104
Registry description
Measured as count of participants.
Number of participants who achieve >= 30 percent body weight reduction
Time frame · From baseline (week 0) to week 104
Registry description
Measured as count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to week 104
Registry description
Measured in centimeter (cm).
Change in waist to height ratio
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to week 104
Registry description
Measured in millimeter of mercury (mmHg).
Ratio to Baseline in Lipids: Total Cholesterol
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Triglycerides
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Free fatty acids
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Ratio to Baseline in Lipids: Non-HDL cholesterol
Time frame · From baseline (week 0) to week 104
Registry description
Measured as ratio.
Change in Body Mass Index (BMI)
Time frame · From baseline (week 0) to week 104
Registry description
Measured in kilograms per meter square (kg/m\^2).
Number of participants who achieve BMI less than 30 kg/m^2
Time frame · At week 104
Registry description
Measured as count of participants.
Change in Glycated Haemoglobin (HbA1c) (percentage points)
Time frame · From baseline (week 0) to week 104
Registry description
Measured in percentage points.
Change in HbA1c (millimoles per mole [mmol/mol])
Time frame · From baseline (week 0) to week 104
Registry description
Measured in mmol/mol.
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Time frame · From baseline (week 0) to week 104
Registry description
Measured as mmol/L.
Change in FPG (milligrams per deciliter [mg/dL])
Time frame · From baseline (week 0) to week 104
Registry description
Measured as mg/dL.
Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Time frame · From baseline (week 0) to week 104
Registry description
Measured as count of participants.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: * Male or female. * Age above or equal to 18 years at the time of signing informed consent. * Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2). Exclusion criteria: * Glycated haemoglobin (HbA1c) \>= 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes.

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