Petrelintide for Obesity and Type 2 Diabetes

Recruiting at 23 trial locations

Overseen By Zealand Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zealand Pharma

Must be taking: Metformin, SGLT2 inhibitors

Must not be taking: Other glucose-lowering drugs

Disqualifiers: Severe hypoglycemia, Obesity surgery, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

216 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.

Eligibility Criteria

This trial is for adults with type 2 diabetes diagnosed at least 6 months ago, currently stable on metformin alone or with SGLT2 inhibitors, and have a BMI of 27 kg/m2 or higher. It's not specified who can't join.

Inclusion Criteria

This seems to be an incomplete criterion.

My BMI is 27 or higher.

I was diagnosed with type 2 diabetes more than 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous injections of petrelintide or placebo

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Petrelintide

Trial Overview The ZUPREME 2 study is testing the effectiveness and safety of three different doses of Petrelintide compared to a placebo in people with overweight/obesity and type 2 diabetes.

Participant Groups

Group I: Treatment E: Petrelintide Dose 3 Experimental Treatment 1 Intervention

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.

Group II: Treatment C: Petrelintide Dose 2 Experimental Treatment 1 Intervention

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.

Group III: Treatment A: Petrelintide Dose 1 Experimental Treatment 1 Intervention

Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.

Group IV: Treatment B: Petrelintide Placebo Dose 1 Placebo Group 1 Intervention

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Group V: Treatment D: Petrelintide Placebo Dose 2 Placebo Group 1 Intervention

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

Group VI: Treatment F: Petrelintide Placebo Dose 3 Placebo Group 1 Intervention

Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.

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