A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
RENEW 4
A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity
3 other identifiers
interventional
285
5 countries
31
Brief Summary
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2026
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
August 4, 2026
CompletedStudy Start
First participant enrolled
August 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 6, 2027
August 4, 2026
July 1, 2026
10 months
July 30, 2026
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage (%).
From baseline (week 0) to end of treatment (week 26)
Secondary Outcomes (2)
Number of Treatment Emergent Adverse Events (TEAEs)
From baseline (week 0) to end of study (week 33)
Number of Treatment Emergent Serious Adverse Events (TESAEs)
From baseline (week 0) to end of study (week 33)
Study Arms (3)
Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2
EXPERIMENTALParticipants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.
Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
EXPERIMENTALParticipants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
PLACEBO COMPARATORParticipants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
Interventions
Cagrilintide will be administered subcutaneously.
Placebo matched to cagrilintide will be administered subcutaneously.
Placebo matched to semaglutide will be administered subcutaneously.
Eligibility Criteria
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.
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (\>=) 30.0 kilograms per square meter (kg/m\^2), or BMI \>= 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.
You may not qualify if:
- History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D).
- Previous dosing of marketed or non-marketed amylin-based compounds.
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (36)
Hope Clin Res & Wellness
Conyers, Georgia, 30094, United States
East West Med Res Inst
Honolulu, Hawaii, 96814, United States
Walgreens - Store 11760
Oak Park, Illinois, 60302, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
The Alliance for Multispecialty Research LLC AMR
Lexington, Kentucky, 40509, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina, 28401, United States
Coastal Carolina Res Ctr
North Charleston, South Carolina, 29405, United States
Health Res of Hampton Roads
Newport News, Virginia, 23606, United States
National Clin Res Inc.
Richmond, Virginia, 23294, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
General Hospital Of Athens Alexandra - Department of Endocrinology, Diabetes Center
Athens, 115 28, Greece
General Hospital Of Athens G Gennimatas - Department of Endocrinology
Athens, 11527, Greece
General Hospital Venizeleio-Pananeio - Diabetic Clinic
Irakleio, 71409, Greece
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
Peristeri, 121 31, Greece
Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic
Thessaloniki, 546 42, Greece
St. Luke's Hospital S.A. - Endocrinology Department and Obesity Clinic
Thessaloniki, 552 36, Greece
Stúdium Egészségház Kft.
Kalocsa, Bács-Kiskun county, 6300, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary
Trial Pharma Kft.
Kecskemét, 6000, Hungary
KomplexLabor Diagnosztika Kft.
Szeged, 6724, Hungary
ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes
Caldas da Rainha, 2500-176, Portugal
ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cirurgia (Esp. Endocrinologia)
Figueira da Foz Municipality, 3094-001, Portugal
Hospital São Francisco, S.A_EECC
Leiria, 2400-110, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-189, Portugal
CVP Hospital Cruz Vermelha_Cardiologia
Lisbon, 1549-008, Portugal
ULS De Gaia/Espinho_H.Santos Silva_Endocrinologia
Vila Nova de Gaia, 4434-502, Portugal
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000, Serbia
Institute for Cardiovascular Diseases of Vojvodina - Sremska Kamenica
Kamenitz, 21204, Serbia
Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
Niš, 18000, Serbia
University Clinical Centre Nis, Clinic for Cardiology
Niš, 18108, Serbia
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, 21000, Serbia
Skånes Universitets Sjukhus
Lund, 222 42, Sweden
Forsåker vårdcentral
Mölndal, 431 33, Sweden
Örebro US - Överviktsenheten
Örebro, 701 85, Sweden
Dalecarlia Clinical Research AB
Rättvik, 795 30, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
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
July 30, 2026
First Posted
August 4, 2026
Study Start
August 4, 2026
Primary Completion (Estimated)
May 18, 2027
Study Completion (Estimated)
July 6, 2027
Last Updated
August 4, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisktrials.com