600 Participants NeededMy employer runs this trial

Petrelintide for Type 2 Diabetes

(ZUPREME-4 Trial)

Recruiting at 1 trial location
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Overseen ByFastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called petrelintide to evaluate its effectiveness in helping people with Type 2 Diabetes (T2D) manage their weight. Participants will receive either petrelintide or a placebo, alongside a reduced-calorie diet and increased physical activity. The trial aims to determine if petrelintide is safe and effective for individuals with T2D who are overweight or obese. This trial may suit those diagnosed with T2D, having a BMI of 27 or higher, and who have struggled to lose weight through dieting. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for T2D.

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

Research has shown that petrelintide is generally safe and well-tolerated. In one study, only 1.9% of participants stopped treatment due to side effects, mainly related to stomach issues. Other studies have found that petrelintide did not cause serious side effects. Some mild side effects were reported, but they were not severe. Petrelintide's safety was similar to that of a placebo, which contains no active drug. Overall, current data suggests that petrelintide has a good safety profile.12345

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Unlike the standard treatments for type 2 diabetes that typically focus on controlling blood sugar through mechanisms like insulin regulation or glucose absorption, Petrelintide offers a fresh approach by potentially mimicking the effects of naturally occurring hormones that regulate appetite and blood sugar. This new mechanism of action could provide better control over blood glucose levels and help in weight management, a significant challenge for many with type 2 diabetes. Researchers are excited about Petrelintide because it targets both blood sugar and weight, offering a comprehensive treatment option that could improve overall disease management.

What evidence suggests that petrelintide might be an effective treatment for Type 2 Diabetes?

In this trial, participants will receive either petrelintide or a placebo. Studies have shown that petrelintide can help people with type 2 diabetes lose weight. In earlier trials, participants lost an average of up to 9.2% of their body weight over 28 weeks. Another study found even more weight loss, about 10.7%. These results suggest that petrelintide might be effective for weight management in those with type 2 diabetes. This treatment mimics a hormone called amylin, which helps control hunger and food intake. Overall, the evidence supports petrelintide as a promising option for managing weight in people with type 2 diabetes.678910

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are overweight or obese (BMI of 27 or higher), have tried and failed to lose weight through diet before, and have been on stable diabetes treatment for at least 3 months. Their blood sugar levels must be moderately high but not severely uncontrolled.

Inclusion Criteria

I have managed my diabetes with the same treatment for at least 90 days.
I have tried to lose weight through diet at least once without success.
I have type 2 diabetes with an HbA1c between 6.5% and 10%.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either petrelintide or placebo once weekly, in conjunction with a reduced-calorie diet and increased physical activity

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Petrelintide

Trial Overview

The study compares a new medication called petrelintide to a placebo. Both groups will also follow a reduced-calorie diet and increase physical activity to see if petrelintide helps with weight loss in people with type 2 diabetes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PetrelintideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Zealand Pharma

Industry Sponsor

Trials
41
Recruited
3,400+

Citations

Petrelintide achieves 10.7% weight loss with 1.5% GI ...

Petrelintide weight loss reaches 10.7% in Phase 2 with only 1.5% GI discontinuation rate, advancing toward Phase 3 trials with Roche.

Petrelintide - Pipeline

ZUPREME-2 is for people with obesity or overweight with type 2 diabetes over 28 weeks of treatment and was initiated in April 2025. 42-week topline results from ...

Petrelintide - A Phase III Study to Evaluate the Efficacy and ...

This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and ...

Petrelintide meets weight-loss goal in Phase II diabetes trial

... study involving people with overweight or obesity and type 2 diabetes, delivering mean weight loss of up to 9.2% after 28 weeks, compared ...

Effectiveness and Persistence of Liraglutide Treatment Among ...

Improved real-world glycaemic outcomes with liraglutide versus other incretin-based therapies in type 2 diabetes. Diabetes Obes Metab. 2014 ...

Petrelintide | IMP

It's important to note that as this is an ongoing clinical trial, the full safety profile and potential side effects of Petrelintide are not yet known.

Petrelintide cuts weight 9.2% in diabetes trial - NLS

Tolerability was largely comparable to placebo: 1.9% of petrelintide-treated participants stopped treatment due to gastrointestinal side effects ...

Two Randomized, Controlled Phase 1 Trials

Petrelintide was well tolerated, with no serious or severe treatment‐emergent adverse events (TEAEs). occurred in 16.7%–33.3% of participants

Petrelintide cuts weight 9.2% in type 2 diabetes trial

Zealand Pharma's petrelintide delivered up to 9.2% weight loss over 28 weeks in people with obesity and type 2 diabetes, with few dropouts.

Zealand Pharma Reports Positive Results from Phase 1b ...

During the trial, petrelintide showed excellent tolerability, with no serious or severe adverse events reported. Gastrointestinal adverse ...