Petrelintide for Obesity

(ZUPREME Trial)

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Zealand Pharma

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

Disqualifiers: Diabetes, Major depression, Cardiovascular, others

Prior Safety Data

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}

Research Team

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.

Trial 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 (Anti-obesity agent)

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

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]

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]