Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

NCT07220759 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9833-8243U1111-1314-93282024-519531-41
• Study Type: interventional
• Target: 330
• Locations: 11 countries
• Sites: 67

Brief Summary

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant 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. For each participant, the study will last for about 1 year and 6 months.

Conditions

Overweight; Obesity; Type 2 Diabetes

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% body weight reduction

  Measured as count of participants.

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

Secondary Outcomes (28)

• 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 lipids: 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 (matched to Cagrilintide)

Interventions

Cagrilintide DRUG

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

Cagrilintide

Placebo (matched to Cagrilintide) 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) \>= 27.0 kilogram per square meter (kg/m\^2).(a\*)
• Diagnosed with type 2 diabetes \>= 180 days before screening.
• Treatment with either lifestyle intervention(a\*), or:
• Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a\*)
• For up to 30% of participants the following concomitant medication is allowed:
• Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a\*) and/or
• Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day \[U/day\]) stable for at least 90 days before screening.(a\*)

You may not qualify if:

• 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 (67)

Univ of Alabama_Birmingham

Birmingham, Alabama, 35294, United States

Location

Chambliss Clinical Trials, LLC

Montgomery, Alabama, 36106, United States

Location

Elite Clinical Network - Tucson

Tucson, Arizona, 85704, United States

Location

Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

Location

Walgreens - Store 4442

Kissimmee, Florida, 34746, United States

Location

Optimal Research Sites

Orange City, Florida, 32763, United States

Location

Center for Diab,Obes & Metab

Pembroke Pines, Florida, 33024, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

MediSphere Medical RC

Evansville, Indiana, 47714, United States

Location

Walgreens - Store 3915

Las Vegas, Nevada, 89146, United States

Location

Chear Center LLC

The Bronx, New York, 10455, United States

Location

Centricity Res New Bern Multispeciality

New Bern, North Carolina, 28562, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group_Bristol

Bristol, Tennessee, 37620, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

TPMG Clinical Research

Newport News, Virginia, 23606, United States

Location

National Clin Res Inc.

Richmond, Virginia, 23294, United States

Location

Buenos Aires Mácula

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAE, Argentina

Location

CICEMO- Consultorio de Investigación Clínica EMO

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BUB, Argentina

Location

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, C1425AGC, Argentina

Location

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, 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 Res Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

Location

Opca bolnica Karlovac

Karlovac, 47000, Croatia

Location

Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

Krapinske Toplice, 49217, Croatia

Location

Poliklinika SLAVONIJA OSIJEK

Osijek, 31000, Croatia

Location

Poliklinika Solmed

Zagreb, 10000, Croatia

Location

Lékařský dům Géčko

České Budějovice, 370 11, Czechia

Location

Milan Kvapil s.r.o.

Prague, 149 00, Czechia

Location

EUC Klinika Praha a.s.

Prague, 150 00, Czechia

Location

Debreceni Egyetem

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

Budapest, Pest County, 1036, Hungary

Location

Óbudai Egészségügyi Centrum

Budapest, Pest County, 1036, Hungary

Location

Komáromi Selye János Kórház

Komárom, 2900, Hungary

Location

Diabmed Dr Popescu Alexandrina SRL

Ploieşti, Prahova, 100179, Romania

Location

CMI Dr. Pletea Noemi SRL

Bacau, 600154, Romania

Location

Diabet Med SRL

Bucharest, 050913, Romania

Location

S.C Milena Sante SRL

Galati, 800001, Romania

Location

Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055, Romania

Location

Nemocnica akademika L. Derera, UNB

Bratislava, 831 01, Slovakia

Location

DIAB s.r.o.

Rožňava, 04801, Slovakia

Location

IRIDIA s.r.o.

Vrútky, 038 61, Slovakia

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, 07345, South Korea

Location

Kyunghee University Medical Center

Seoul, 130-872, South Korea

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Centre hospitalier universitaire vaudois CHUV

Lausanne, 1011, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Diabetes Adipositas Zentrum Zürich

Zollikerberg, 8125, Switzerland

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

Attenborough Surgery

Bushey, Hertfordshire, WD23 2NN, United Kingdom

Location

Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre

London, W6 7HY, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Interventions

cagrilintide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

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 12, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (21); KR (6); GB (5); AR (3); HU (4); CA (9); SL (3); RO (5); CR (4); CH (4); CZ (3)