RENEW 4

RecruitingPhase 3

A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight

A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Estimated enrollment

285

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07745504

Org study IDNN9833-8550

Secondary ID2025

Secondary ID2025-524249-29European Medical Agency (EMA)

Secondary IDU1111-1328-5168World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-08-04actual

Study start2026-08-04actual

Last update posted2026-09-04actual

Primary completion2027-05-18estimated

Study completion2027-07-06estimated

Assets

Investigational agents

CagriSema / cagrilintide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

1 endpoint

Primary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 26)

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 33)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Time frame:From baseline (week 0) to end of study (week 33)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.