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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name RENEW 4

NCTNCT07745504 (opens ClinicalTrials.gov in a new tab)Other idNN9833-8550Other idU1111-1328-5168Other id2025-524249-29Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
285 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
6 countries

United States, Greece, Hungary, Portugal, Serbia, Sweden

Start
4 Aug 2026
Primary completion
18 May 2027 (estimated)
Completion
6 Jul 2027 (estimated)
First posted
4 Aug 2026
Last update posted
4 Sept 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 3

    RENEW 4

    NCT07745504

    4 Aug 2026 to est. 6 Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CagrilintideDrug
  • Placebo cagrilintideDrug
  • Placebo semaglutideDrug

Arms3

  • Experimental

    Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2

    Participants 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.

  • Experimental

    Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1

    Participants 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 comparator

    Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1

    Participants 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

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

    Registry description

    Measured as percentage (%).

Secondary outcomes(2)

  1. Number of Treatment Emergent Adverse Events (TEAEs)

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

    Registry description

    Measured as count of events.

  2. Number of Treatment Emergent Serious Adverse Events (TESAEs)

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

    Registry description

    Measured as count of events.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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