Petrelintide for Obesity

(ZUPREME Trial)

Recruiting at 31 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

494 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Petrelintide for obesity?

The research mentions that Retatrutide, a drug targeting incretin receptors, shows promise in obesity management. This suggests that drugs affecting incretin receptors, like Petrelintide, may also be effective for obesity. ^{1 2 3 4 5}

Eligibility Criteria

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

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

* 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.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Update on obesity pharmacotherapy. [2014]

5. Hungary pubmed.ncbi.nlm.nih.gov

[The pharmacological treatment of obesity: past, present and future]. [2018]