Cagrilintide for Obesity

(RENEW 1 Trial)

Not yet recruiting at 39 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must not be taking: Weight management drugs, Amylin-based compounds

Disqualifiers: Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 64 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a new medication, cagrilintide (an investigational drug for weight loss), can assist individuals who are overweight or have obesity in losing weight. Participants will receive either cagrilintide or a placebo (a harmless, inactive substance), with a higher likelihood of receiving the actual medication. The trial spans about a year and a half, and researchers will closely monitor for any side effects. Suitable candidates for this trial have a BMI of 30 or higher (a measure of body fat based on height and weight) or a BMI of 27 or higher with a weight-related health issue such as high blood pressure or sleep apnea, and have previously attempted weight loss through diet without success. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any weight management medication within 180 days before the trial starts.

Is there any evidence suggesting that cagrilintide is likely to be safe for humans?

Research has shown that cagrilintide is generally well-tolerated. In one study, participants taking cagrilintide lost about 9.7% of their body weight by week 26, indicating its effectiveness. Another study found that cagrilintide caused less vomiting compared to similar weight loss medications like semaglutide and liraglutide.

These findings suggest that while cagrilintide can have side effects, they might be less severe than those of other treatments. Overall, evidence indicates that cagrilintide is safe for most people, but it might not be suitable for everyone. Trial participants will be closely monitored for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cagrilintide is unique because it targets obesity through a novel mechanism of action. Unlike many existing treatments for obesity, which primarily focus on appetite suppression or metabolic rate enhancement, cagrilintide is designed to mimic a hormone called amylin, which helps regulate appetite and food intake by signaling fullness to the brain. This approach offers a different pathway for managing weight, potentially leading to better long-term results. Researchers are excited because cagrilintide is administered just once a week via a subcutaneous injection, which could improve patient adherence compared to daily treatments.

What evidence suggests that cagrilintide might be an effective treatment for obesity?

Research has shown that cagrilintide can aid in weight loss. In one study, participants taking cagrilintide lost an average of 11.8% of their body weight. Another study found that individuals without diabetes lost up to 22.7% of their body weight. These promising results suggest that cagrilintide can effectively assist people with obesity in reducing their weight. In this trial, participants will receive either cagrilintide or a placebo. The medication works by promoting a feeling of fullness and satisfaction, which can help decrease food intake. ^{1 4 6 7 8}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for individuals living with overweight or obesity. Participants must be willing to receive either the investigational medicine, Cagrilintide, or a placebo without knowing which one they will get. The study requires commitment for approximately 1 year and 6 months.

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

I am either female or male by birth.

I am 18 years old or older.

Exclusion Criteria

I plan to start or have started weight management medication in the last 6 months.

I have never taken amylin-based drugs before.

I have a history of diabetes (type 1 or 2).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cagrilintide or placebo subcutaneously once weekly

64 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cagrilintide

Trial Overview The effectiveness of Cagrilintide in reducing body weight among people with obesity is being tested against a placebo. Participants have a higher chance (2:1 ratio) of receiving Cagrilintide over the placebo, and treatment allocation is random.

How Is the Trial Designed?

Group I: Cagrilintide Experimental Treatment 1 Intervention

Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40544432/

Cagrilintide-Semaglutide in Adults with Overweight or ... Once-weekly cagrilintide-semaglutide (at a dose of 2.4 mg each) resulted in a significantly lower body weight than placebo in adults with obesity and type 2 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2502081

Coadministered Cagrilintide and Semaglutide in Adults ... In a phase 2 trial, cagrilintide at a dose of 2.4 mg led to a 9.7% weight reduction by week 26. Because the combination of therapies with ...

3. gastroenterologyadvisor.com gastroenterologyadvisor.com/news/combining-cagrilintide-with-semaglutide-amplifies-weight-loss-outcomes/

Combining Cagrilintide With Semaglutide Amplifies Weight ... The dual therapy was associated with a 5.5% additional weight loss compared with semaglutide (P <.001), an 8.9% additional weight loss compared ...

4. pharmacytimes.com pharmacytimes.com/view/cagrilintide-demonstrates-promising-results-as-monotherapy-for-obesity-management

Cagrilintide Demonstrates Promising Results as ... The results demonstrated that cagrilintide displayed clinically meaningful weight loss, with an average body weight reduction of 11.8% compared ...

5. diabetes.org diabetes.org/newsroom/press-releases/cagrisema-demonstrates-significant-weight-loss-adults-obesity

CagriSema Demonstrates Significant Weight Loss in Adults ... Once-weekly medication results in weight loss of up to 22.7% in adults without diabetes and 15.7% in those with type 2 diabetes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642503/

Efficacy and Safety of Cagrilintide Alone and in ... Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.

7. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/easd2025/garvey1/documents/Garvey_EASD25_REDEFINE_1_Cagrilintide_Short_oral_with_disclosures.pdf

Efficacy and safety of cagrilintide 2.4 mg in adults with ... Efficacy and safety of cagrilintide 2.4 mg in adults with overweight/obesity: Data from REDEFINE 1. W. Timothy Garvey1*, Lei Liu2, John ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07220759

Weight Loss in People Living With Overweight or Obesity ... This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight.