NCT07745504 · Novo Nordisk A/S
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
(RENEW 4)
What this study is about
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.
View original scientific description
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
DRUG
Cagrilintide
Cagrilintide will be administered subcutaneously.
DRUG
Placebo cagrilintide
Placebo matched to cagrilintide will be administered subcutaneously.
DRUG
Placebo semaglutide
Placebo matched to semaglutide will be administered subcutaneously.
Primary outcome measures
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured as percentage (%).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Conyers, Georgia
- Honolulu, Hawaii
- Oak Park, Illinois
- Indianapolis, Indiana
- Lexington, Kentucky
- Greensboro, North Carolina
- Wilmington, North Carolina
- North Charleston, South Carolina
- Newport News, Virginia
- Richmond, Virginia
- Winchester, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations