Petrelintide for Obesity
(ZUPREME-3 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 help manage weight. Participants will follow a reduced-calorie diet and increase physical activity; some will receive petrelintide, while others will receive a placebo (a substance with no active treatment). The goal is to determine if petrelintide is safe and effective for weight loss in individuals who are overweight or obese and have at least one other weight-related health issue, excluding Type 2 Diabetes. This study suits those with a BMI of 30 or more, or 27 with additional weight-related conditions, who have previously tried and not succeeded with dieting. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking weight management solution.
Is there any evidence suggesting that petrelintide is likely to be safe for humans?
Research has shown that petrelintide, a treatment under study for weight management, appears promising based on earlier studies. One study found that participants taking petrelintide generally did not experience serious side effects, indicating the dose was well tolerated. Those receiving the highest dose lost an average of 8.6% of their body weight, suggesting the treatment's potential effectiveness.
However, since this clinical trial is still ongoing, the researchers have not yet fully understood all the safety aspects and possible side effects of petrelintide. Overall, early findings suggest that petrelintide might be a safe option for helping individuals with obesity or overweight conditions manage their weight.12345Why do researchers think this study treatment might be promising for obesity?
Petrelintide is unique because it offers a new approach to tackling obesity by mimicking the hormone amylin, which helps regulate appetite and body weight. Unlike current treatments, which are often appetite suppressants or metabolic boosters, Petrelintide specifically targets the brain's satiety centers, potentially leading to more natural weight loss without extreme dieting. Researchers are excited about its potential to provide a more balanced and sustainable weight management option with fewer side effects.
What evidence suggests that petrelintide might be an effective treatment for obesity?
Research has shown that petrelintide, which participants in this trial may receive, can significantly aid in weight loss. One study found that individuals using petrelintide lost up to 10.7% of their body weight over 42 weeks, while those on a placebo lost only 1.7%. Another study reported that 34% to 56% of people treated with petrelintide lost at least 10% of their body weight. These findings highlight petrelintide's potential to help manage weight in individuals with obesity. Most participants tolerated it well, with mild side effects like nausea being the most common.678910
Are You a Good Fit for This Trial?
This trial is for people who are overweight or have obesity (BMI of 30 or higher, or 27+ with a related health issue), have tried and failed to lose weight through diet before, and do not have type 2 diabetes.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either petrelintide or placebo once weekly, in conjunction with a reduced-calorie diet and increased physical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Petrelintide
Trial Overview
The study compares petrelintide, a new medication, to a placebo. All participants also follow a reduced-calorie diet and increase physical activity. The goal is to see if petrelintide helps with weight loss.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Zealand Pharma
Industry Sponsor
Citations
a randomised, double-blind, placebo-controlled, phase 2 trial
Bodyweight continued to decline to week 42, with reductions of up to -10·7% with petrelintide. The most common adverse event with petrelintide ...
Petrelintide, a human amylin analogue for the treatment of ...
Petrelintide achieved clinically meaningful weight reduction and had similar gastrointestinal tolerability to that of placebo apart from predominantly mild ...
Roche announces positive Phase II results for petrelintide ...
Petrelintide achieved up to 10.7% mean body weight reduction at week 42 versus 1.7% with placebo (p-value<0.001) while demonstrating placebo- ...
NCT06662539 | Once-weekly Petrelintide Versus Placebo ...
The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and ...
Petrelintide Achieves Weight Loss for Adults With Obesity
To week 42, there was a continuing decline in body weight, with reductions of up to −10.7% with petrelintide. Nausea was the most common ...
Long-acting Amylin Analog Petrelintide, a Rising Star in Anti ...
The Data of the phase 1 single ascending dose trial suggest that the dose was well tolerated and showed potential to reduce body weight [25].
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.
A Phase III Study to Evaluate the Efficacy and Safety of ...
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased ...
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biopharminternational.com
biopharminternational.com/view/zealand-pharma-and-roche-advance-petrelintide-to-phase-3-for-chronic-weight-managementZealand Pharma and Roche Advance Petrelintide to Phase ...
Phase 3 will assess efficacy, safety, and tolerability of once-weekly subcutaneous petrelintide in patients with overweight or obesity, ...
10.
ctv.veeva.com
ctv.veeva.com/study/a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-petrelintide-in-participants-with-overweighA Phase III Study to Evaluate the Efficacy and Safety of ...
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and ...
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