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

NCT07011667 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: NN9838-8484U1111-1318-6372
• Study Type: interventional
• Target: 609
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in body weight

  Measured as percentage change.

  From baseline (week 0) to week 80

Secondary Outcomes (39)

• Number of participants who achieve greater than or equals (≥) 20% weight reduction

  From baseline (week 0) to week 80

• Number of participants who achieve ≥ 25% weight reduction

  From baseline (week 0) to week 80

• Number of participants who achieve ≥ 30% weight reduction

  From baseline (week 0) to week 80

• Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)

  From baseline (week 0) to week 80

• Number of participants who achieve BMI < 30 kg/m^2

  From baseline (week 0) to week 80

Study Arms (2)

CagriSema

EXPERIMENTAL

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.

Drug: CagriSema (Cagrilintide B and Semaglutide I)

Placebo

PLACEBO COMPARATOR

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.

Drug: CagriSema (Cagrilintide B and Semaglutide I); Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Interventions

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.

Placebo

CagriSema (Cagrilintide B and Semaglutide I) DRUG

CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.

CagriSema; 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 (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening.
• Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.

You may not qualify if:

• Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole 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 (46)

FDRC

Costa Mesa, California, 92627, United States

Location

Linda Vista Health Care Ctr

San Diego, California, 92111, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Northeast Research Institute

Fleming Island, Florida, 32003, United States

Location

Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States

Location

South Broward Research LLC

Miramar, Florida, 33027, United States

Location

Florida Inst For Clin Res LLC

Orlando, Florida, 32825, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Cnt for Diab,Obes, and Metab

Pembroke Pines, Florida, 33024, United States

Location

Hope Clin Res & Wellness

Conyers, Georgia, 30094, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Endeavor Health

Skokie, Illinois, 60077, United States

Location

Evanston Premier Hlthcr Res

Skokie, Illinois, 60077, United States

Location

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

Location

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States

Location

Northern Pines Hlth Ctr, PC

Buckley, Michigan, 49620, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

Amicis Centers of Clinical Research

St Louis, Missouri, 63128, United States

Location

Mercury Str Med Grp, PLLC

Butte, Montana, 59701, United States

Location

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

Location

Great Lakes Medical Research

Westfield, New York, 14787, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Medication Mgmnt, LLC_Grnsboro

Greensboro, North Carolina, 27405, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Accellacare_NC

Raleigh, North Carolina, 27609, United States

Location

Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

New Venture Medical Research

Wadsworth, Ohio, 44281-9236, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

Location

Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States

Location

Coastal Carolina Res Ctr

North Charleston, South Carolina, 29405, United States

Location

Hillcrest Clinical Research

Simpsonville, South Carolina, 29681-1538, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

Amarillo Medical Specialists

Amarillo, Texas, 79124, United States

Location

Velocity Clin Res, Dallas

Dallas, Texas, 75230, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Radiance Clinical Research

Lampasas, Texas, 76550, United States

Location

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

Location

Northeast Clinical Research of San Antonio

Schertz, Texas, 78154, United States

Location

Washington Cntr Weight Mgmt

Arlington, Virginia, 22206, United States

Location

Health Res of Hampton Roads

Newport News, Virginia, 23606, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Obesity

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
• Masking Details: Participants in the main phase will be randomised in double blinded manner to receive either CagriSema or matching placebo. In the extension phase, eligible participants will be re-randomised and enter the open label extension phase. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 9, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 17, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (46)