Recruiting

RENEW 2Cagrilintide for Weight Management in Overweight or Obesity with Type 2 Diabetes

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Study Aim

This study aims to evaluate the effectiveness of Cagrilintide for weight management in individuals who are overweight or have obesity and are also living with type 2 diabetes.

What is being tested

Cagrilintide

+ Placebo (matched to Cagrilintide)

Drug
Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Study ContactNovo Nordisk
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 5, 2025

Actual date on which the first participant was enrolled.

This clinical trial investigates whether a new medicine called cagrilintide can help people who are overweight or have obesity, as well as type 2 diabetes, to lose weight. This study is important because managing weight is a crucial part of controlling type 2 diabetes, which can be challenging for many people. Cagrilintide is still under study and not yet available for doctors to prescribe. By exploring its effectiveness and safety, this research aims to contribute to potential new treatments that could support better health outcomes for those struggling with these conditions. In the study, participants will receive either cagrilintide or a placebo, which is a substance with no active medication. The assignment to either the medicine or placebo is random, but participants have a higher chance, specifically two times more likely, of receiving cagrilintide. The medication or placebo will be administered, and participants will be monitored for any changes in body weight and possible side effects. The entire duration of the study for each participant is approximately one year and six months, allowing researchers to gather comprehensive data on the long-term effects and safety of cagrilintide.

Official TitleEfficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes
NCT07220759
Principal SponsorNovo Nordisk A/S
Study ContactNovo Nordisk
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

330 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

7 inclusion criteria required to participate
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).

History of at least one self-reported unsuccessful dietary effort to lose body weight.(a\*)

Age 18 years or above at the time of signing the informed consent.

Show More Criteria

3 exclusion criteria prevent from participating
Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\*)

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.

Group II

Placebo
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 69 locations

Recruiting

Univ of Alabama_Birmingham

Birmingham, United StatesOpen Univ of Alabama_Birmingham in Google Maps
Recruiting

Chambliss Clinical Trials, LLC

Montgomery, United States
Recruiting

Elite Clinical Network - Tucson

Tucson, United States
Recruiting

Scripps Whittier Diabetes Inst

La Jolla, United States
Recruiting
69 Study Centers