Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

NCT07220642 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9833-8242U1111-1314-89062024-519530-24
• Study Type: interventional
• Target: 300
• Locations: 10 countries
• Sites: 40

Brief Summary

This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

• Relative change in body weight

  Measured as percentage (%) of body weight.

  From baseline (week 0) to end of treatment (week 64)

• Number of participants with achievement of greater than or equals (>=) 5 percent (%) body weight reduction

  Measured as count of participants.

  From baseline (week 0) to end of treatment (week 64)

Secondary Outcomes (26)

• Number of participants with achievement of >= 10 % body weight reduction

  From baseline (week 0) to end of treatment (week 64)

• Number of participants with achievement of >= 15 % body weight reduction

  From baseline (week 0) to end of treatment (week 64)

• Change in waist circumference

  From baseline (week 0) to end of treatment (week 64)

• Ratio to baseline in triglycerides

  From baseline (week 0) to end of treatment (week 64)

• Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)

  From baseline (week 0) to end of treatment (week 64)

Study Arms (2)

Cagrilintide

EXPERIMENTAL

Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.

Drug: Cagrilintide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.

Drug: Placebo

Interventions

Cagrilintide DRUG

Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Cagrilintide

Placebo DRUG

Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Placebo

Eligibility Criteria

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

You may qualify if:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
• Female or male (sex at birth)
• Age 18 years or above at the time of signing the informed consent
• History of at least one self-reported unsuccessful dietary effort to lose body weight (a\*)
• Body mass index (BMI) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\*)

You may not qualify if:

• History of type 1 or type 2 diabetes (a\*)
• Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a\*)
• Previous dosing of marketed or non-marketed amylin-based compounds (a\*) (a\*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (40)

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Univ of Colorado at Denver

Aurora, Colorado, 80045, 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

Walgreens - Store 11760

Oak Park, Illinois, 60302, United States

Location

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

CIPREC Pueyrredon

Buenos Aires, C1119ACN, Argentina

Location

CEDIC Centro de Investigación Clínica

CABA, C1060ABA, Argentina

Location

Sydney Cardiometabolic Centre

Liverpool, New South Wales, 2170, Australia

Location

Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton Medical Rsrch Grp

Hamilton, Ontario, L8L 5G4, Canada

Location

Wharton Medical Clinic Clinical Trials (Hamilton)

Hamilton, Ontario, L8L 5G8, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Centricity Research Oshawa

Oshawa, Ontario, L1J 2K9, Canada

Location

Centricity Research Toronto

Toronto, Ontario, M4G 3E8, Canada

Location

Centricity Research Mirabel

Mirabel, Quebec, J7J 2K8, Canada

Location

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

Saint-Herblain, 44800, France

Location

Centre de Recherche Clinique Portes Du Sud

Vénissieux, 69200, France

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany

Location

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, 23758, Germany

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCS

Rome, RM, 00168, Italy

Location

AOUP Giaccone Palermo

Palermo, Sicily, 90127, Italy

Location

A.O.U. Bologna_ Policlinico S.Orsola Malpighi

Bologna, 40138, Italy

Location

IRCCS Ospedale San Raffaele Milano

Milan, 20132, Italy

Location

Haukeland Universitetssykehus

Bergen, 5021, Norway

Location

Drammen sykehus - Vestre Viken HF

Drammen, 3004, Norway

Location

St. Olavs Hospital HF_Endokrinologisk avdeling

Trondheim, NO-7030, Norway

Location

Osteo-Medic s.c. A. Racewicz, J. Supronik

Bialystok, 15-351, Poland

Location

Care Clinic Sp. z o. o.

Katowice, 40-568, Poland

Location

Terpa Sp. z o.o. Sp. k.

Lublin, 20-333, Poland

Location

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

Oak Tree Surgery

Liskeard, Cornwall, PL14 3XA, United Kingdom

Location

North Coast Medical Ltd

Newquay, Cornwall, TR7 1RU, United Kingdom

Location

Brunel Medical Practice

Torquay, Devon, TQ1 4QX, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

cagrilintide

Condition Hierarchy (Ancestors)

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: 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: October 23, 2025
• First Posted: October 24, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): June 29, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (8); IT (4); PL (4); GB (3); FR (2); AU (2); AR (2); DE (3); NO (3); US (9)