Petrelintide for Obesity

(ZUPREME Trial)

Not currently recruiting at 41 trial locations

Overseen By Mira Baron

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zealand Pharma

Must not be taking: Glucose lowering agents, Weight loss meds

Disqualifiers: Diabetes, Major depression, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 42 weeks

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 weight loss, along with its safety and tolerability. The trial compares different doses of petrelintide to a placebo to identify the most effective option. It seeks participants with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with conditions such as high blood pressure or cholesterol issues. Participants will self-administer the treatment once a week. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking any medication or supplements for weight loss, you must have stopped them at least 6 months before the trial.

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

Research has shown that petrelintide is generally safe for humans. In earlier studies, participants took petrelintide for 16 weeks, and researchers closely monitored their health to ensure safety. Most participants responded well to the treatment. Safety checks always preceded any dose increases to ensure it was safe to continue.

Another study compared different doses of petrelintide with a placebo to assess both effectiveness and safety. Some side effects occurred, but they were mostly mild. This suggests that petrelintide is safe for humans, though monitoring for any side effects during trials remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for obesity?

Researchers are excited about petrelintide for obesity because it offers a new approach by targeting specific pathways in the body that regulate appetite and energy balance. Unlike standard treatments like lifestyle changes, medications, or surgery, which often focus on reducing calorie intake or altering metabolism, petrelintide works by mimicking certain hormones that signal satiety, potentially reducing hunger and promoting weight loss. Additionally, petrelintide is self-administered as a weekly injection, which may improve adherence compared to daily medications. This innovative mechanism and convenient delivery could make it a promising new option for managing obesity.

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

Research has shown that petrelintide can aid in weight loss. In earlier studies, participants using petrelintide lost up to 8.6% of their body weight, while those on a placebo lost only 1.7%. These studies also found the treatment to be safe and well-tolerated. The promising weight loss results suggest that petrelintide could be a viable option for those seeking to lose weight. Participants in this trial will receive one of several doses of petrelintide or a placebo to further assess its effectiveness and safety. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 30 or more, or a BMI of at least 27 with hypertension or dyslipidemia. Women must not be pregnant, breastfeeding, and willing to use contraception. Participants should be able to self-administer injections and follow the trial protocol.

Inclusion Criteria

* A woman of nonchildbearing potential. OR * A woman of childbearing potential (WOCBP) who is not pregnant, does not intend to be pregnant, not lactating and is willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial and for 10 weeks after the last injection of the investigational medicinal product (IMP).

I can follow the study rules and give myself injections.

I am overweight with a BMI over 30, or over 27 with high blood pressure or cholesterol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive once-weekly subcutaneous injections of petrelintide or placebo for weight management

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Petrelintide

Trial Overview The study aims to compare different doses of petrelintide (a new medication) against a placebo in terms of their effect on body weight reduction. It also evaluates the safety and tolerability of petrelintide in individuals who are obese or overweight with certain health conditions.

How Is the Trial Designed?

Group I: Petrelintide Dose 5 Experimental Treatment 1 Intervention

Participants will self-inject petrelintide dose 5 subcutaneously once a week.

Group II: Petrelintide Dose 4 Experimental Treatment 1 Intervention

Participants will self-inject petrelintide dose 4 subcutaneously once a week.

Group III: Petrelintide Dose 3 Experimental Treatment 1 Intervention

Participants will self-inject petrelintide dose 3 subcutaneously once a week.

Group IV: Petrelintide Dose 2 Experimental Treatment 1 Intervention

Participants will self-inject petrelintide dose 2 subcutaneously once a week.

Group V: Petrelintide Dose 1 Experimental Treatment 1 Intervention

Participants will self-inject petrelintide dose 1 subcutaneously once a week.

Group VI: Placebo Placebo Group 1 Intervention

Participants will self-inject matching placebo to petrelintide subcutaneously once a week.

Who Is Running the Clinical Trial?

Zealand Pharma

Lead Sponsor

Trials

41

Recruited

3,400+

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

There are three main drugs approved for long-term obesity treatment: orlistat (5-8 kg weight loss but with gastrointestinal side effects), lorcaserin (4-7 kg weight loss with few side effects), and a combination of phentermine and topiramate (8-10 kg weight loss, but requires pregnancy verification).

For patients with chronic diseases like diabetes or depression, it's important to choose medications that not only treat the condition but also promote weight loss, as some drugs can cause weight gain or have a neutral effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on obesity pharmacotherapy. Bray, GA., Ryan, DH.[2014]

Obesity management requires a combination of lifestyle changes, behavioral therapy, and pharmacological treatments, but drug treatments often yield only modest results and weight is typically regained after stopping the medication.

Currently, orlistat is the only long-term anti-obesity drug available, while liraglutide, a GLP-1 analogue, shows promise as a new treatment option in development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The pharmacological treatment of obesity: past, present and future]. Simonyi, G., Pados, G., Medvegy, M., et al.[2018]

Retatrutide, a triple agonist targeting incretin receptors, has shown significant weight loss and reductions in glycated hemoglobin (HbA1c) in phase-2 trials for individuals with type 2 diabetes mellitus (T2DM), as well as substantial weight loss in non-T2DM individuals, although gastrointestinal side effects were noted.

Concerns about cardiovascular safety have emerged due to dose-dependent increases in heart rate and mild to moderate cardiac arrhythmias, highlighting the need for long-term cardiovascular outcome trials to assess its safety in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retatrutide: a triple incretin receptor agonist for obesity management. Ray, A.[2023]

Antiobesity medications can support weight management in conjunction with a balanced diet and exercise, particularly for patients with obesity or overweight who have related health issues, as approved by the FDA.

While off-label medications may lead to modest weight loss and improvements in cardiovascular risk factors, they are not effective on their own and often result in weight regain after discontinuation, highlighting the importance of medical supervision and behavior modification in weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medications as adjunct therapy for weight loss: approved and off-label agents in use. Moyers, SB.[2006]

Citations

1. zealandpharma.com zealandpharma.com/media/vrypyzy1/zealand-pharma-at-obesity-week-2024.pdf

Safety, Tolerability, and Clinical Effects of Petrelintide ( ... ... of clinically relevant weight loss after 16 weeks. Petrelintide will be further investigated in a Phase 2 obesity trial. Page 17. Access this presentation here.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06662539

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 tolerability.

3. blog.profil.com blog.profil.com/blog/long-acting-amylin-analog-petrelintide

Long-acting Amylin Analog Petrelintide, a Rising Star in Anti ... Clinically meaningful body weight reductions were observed, with petrelintide achieving up to -8.6% weight loss compared to -1.7% with placebo ...

4. biospace.com biospace.com/zealand-pharma-announces-positive-topline-results-from-the-phase-1b-16-week-multiple-ascending-dose-clinical-trial-with-long-acting-amylin-analog-petrelintide

Zealand Pharma announces positive topline results from ... The mean body weight decreased by 8.6% from baseline among participants completing treatment with high dose petrelintide while placebo resulted ...

5. zealandpharma.com zealandpharma.com/media/kiioen11/zealand-pharma_petrelintide-part-2-mad-16-week-trial_conference-call-20-june-2024.pdf

Petrelintide Part 2 MAD 16-week trial Topline results are from an interim data cut at 16 weeks, which was at the end of the treatment period. Final results will be based on all ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06926842

NCT06926842 | Efficacy and Safety of Petrelintide in ... The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or ...