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

NCT06780449 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9838-7859U1111-1304-74302024-512144-39
• Study Type: interventional
• Target: 400
• Locations: 6 countries
• Sites: 36

Brief 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

Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in body weight

  Measured in percentage (%).

  From baseline (week 0) to week 104

Secondary Outcomes (59)

• Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction

  From baseline (week 0) to week 104

• Number of participants who achieve >= 25 percent body weight reduction

  From baseline (week 0) to week 104

• Number of participants who achieve >= 30 percent body weight reduction

  From baseline (week 0) to week 104

• Change in waist circumference

  From baseline (week 0) to week 104

• Change in waist to height ratio

  From baseline (week 0) to week 104

Study Arms (2)

CagriSema

EXPERIMENTAL

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.

Drug: Cagrilintide; Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo cagrilintide; Drug: Placebo semaglutide

Interventions

Cagrilintide DRUG

Participants will receive cagrilintide subcutaneously.

CagriSema

Semaglutide DRUG

Participants will receive semaglutide subcutaneously.

CagriSema

Placebo semaglutide DRUG

Participants will receive placebo matched to semaglutide subcutaneously.

Placebo

Placebo cagrilintide DRUG

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (36)

Valley Clinical Trials

Covina, California, 91723, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06519, United States

Location

East West Medical Research Institute_Honolulu

Honolulu, Hawaii, 96814, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group_Bristol

Bristol, Tennessee, 37620, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Washington Cntr Weight Mgmt

Arlington, Virginia, 22206, United States

Location

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

Brussels, 1200, Belgium

Location

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, 2650, Belgium

Location

UZ Leuven - Endocrinology

Leuven, 3000, Belgium

Location

CHU Helora - Hôpital de Mons - Site Constantinople

Mons, 7000, Belgium

Location

Dr. M.B. Jones Inc

Victoria, British Columbia, V8V 4A1, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8L 5G4, Canada

Location

Alpha Recherche Clinique - Lebourgneuf

Québec, G2J 0C4, Canada

Location

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Location

Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

Esbjerg, 6700, Denmark

Location

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, 2900, Denmark

Location

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, 2650, Denmark

Location

Sjællands Universitetshospital, Køge - Medicinsk Afdeling

Køge, 4600, Denmark

Location

ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal

Location

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, 1250-189, Portugal

Location

CUF Descobertas

Lisbon, 1998-018, Portugal

Location

Hospital Cuf Descobertas S.A.

Lisbon, 1998-018, Portugal

Location

Unidade Local de Saude de Sao Joao E.P.E

Porto, 4200-319, Portugal

Location

Hospital Luz Arrabida, S.A.

Vila Nova de Gaia, 4400-346, Portugal

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Addenbrooke's Hospital_Cambridge

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospital Coventry - WISDEM Centre

Coventry, CV2 2DX, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

Royal London Hospital - Blizard Institute

London, E1 2AJ, United Kingdom

Location

Joint Clinical Research Facility - Swansea

Swansea, SA2 8PP, United Kingdom

Location

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

cagrilintide; semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): August 28, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (7); BE (4); DK (5); PT (6); US (10); CA (4)