A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

NCT06388187 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN9838-7749U1111-1298-34512023-509273-24
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 25

Brief Summary

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Relative change in body weight

  Measured in percentage (%).

  From baseline (week 0) to end of treatment (week 68)

• Achievement of ≥5% weight reduction

  Measured as count of participant.

  From baseline (week 0) to end of treatment (week 68)

Secondary Outcomes (13)

• Achievement of ≥10% weight reduction

  From baseline (week 0) to end of treatment (week 68)

• Achievement of ≥15% weight reduction

  From baseline (week 0) to end of treatment (week 68)

• Achievement of ≥20% weight reduction

  From baseline (week 0) to end of treatment (week 68)

• Change in waist circumference

  From baseline (week 0) to end of treatment (week 68)

• Change in systolic blood pressure

  From baseline (week 0) to end of treatment (week 68)

Study Arms (4)

CagriSema Dose 1

EXPERIMENTAL

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.

Drug: Cagrilintide; Drug: Semaglutide

Placebo Dose 1

PLACEBO COMPARATOR

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.

Drug: Placebo

CagriSema Dose 2

ACTIVE COMPARATOR

Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.

Drug: Cagrilintide; Drug: Semaglutide

Placebo Dose 2

PLACEBO COMPARATOR

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.

Drug: Placebo

Interventions

Cagrilintide DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

CagriSema Dose 1; CagriSema Dose 2

Semaglutide DRUG

Participants will receive once-weekly semaglutide subcutaneously.

CagriSema Dose 1; CagriSema Dose 2

Placebo DRUG

Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.

Placebo Dose 1; Placebo Dose 2

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 (≥) 30.0 kilogram per meter square (kg/m\^2) or
• BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

You may not qualify if:

• Glycated haemoglobin (HbA1c) ≥6.5% (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 (25)

Aurora FDRC Inc.

Costa Mesa, California, 92627, United States

Location

Clinical Trial Res Assoc,Inc

Plantation, Florida, 33324, United States

Location

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Washington Cntr Weight Mgmt

Arlington, Virginia, 22206, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Wharton Medical Clinic Clinical Trials (Hamilton)

Hamilton, Ontario, L8L 5G8, Canada

Location

Hospices Civils de Lyon-Hopital Lyon Sud-1

Pierre-Bénite, 69310, France

Location

Hospices Civils de Lyon-Hopital Lyon Sud

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

Saint-Herblain, 44800, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

Toulouse, 31059, France

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany

Location

AmBeNet GmbH

Leipzig, 04107, Germany

Location

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

Location

Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann

Witten, 58455, Germany

Location

The Health Centre

Bradford-on-Avon, BA15 1DQ, United Kingdom

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

Staploe Medical Centre

Soham, CB7 5JD, United Kingdom

Location

Joint Clinical Research Facility - Swansea

Swansea, SA2 8PP, 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: April 24, 2024
• First Posted: April 29, 2024
• Study Start: June 24, 2024
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (5); GB (6); FR (4); US (7); CA (3)