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NCT Number: NCT07745504

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital Of Athens Alexandra - Department of Endocrinology, Diabetes Center, Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously.

Placebo Cagrilintide

Drug

Placebo matched to cagrilintide will be administered subcutaneously.

Placebo Semaglutide

Drug

Placebo matched to semaglutide will be administered subcutaneously.

Primary outcomes

  1. Relative change in body weight

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

    Measured as percentage (%).

Secondary outcomes

  1. Number of Treatment Emergent Adverse Events (TEAEs)

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

    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)

    Measured as count of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: RENEW 4

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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