Petrelintide for Obesity and Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called petrelintide to determine its safety and effectiveness in helping people with obesity and type 2 diabetes manage their condition. Participants will receive varying doses of petrelintide or a placebo to compare outcomes. The trial suits individuals diagnosed with type 2 diabetes for at least six months, with a BMI of 27 or higher, and who are already taking metformin, with or without another specific diabetes medication. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
You can continue taking metformin and sodium-glucose cotransporter 2 inhibitors as long as your treatment has been stable for at least 90 days before the trial. Other glucose-lowering drugs or weight loss medications should not have been used recently.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that petrelintide was well-tolerated in past studies. In an early study, petrelintide helped reduce body weight and was generally well-received by participants, suggesting it might be safe to use. However, since this is based on earlier research, not all possible side effects may be known. Prospective participants should consult the study team to understand what to expect.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about petrelintide because it offers a new approach to managing obesity and type 2 diabetes. Unlike current treatments like metformin or GLP-1 receptor agonists, petrelintide is a novel peptide that mimics certain hormones in the body to help regulate appetite and glucose levels. This potentially unique mechanism could provide more effective weight management and better glucose control, addressing both core issues of these conditions in one go. Furthermore, petrelintide is administered via subcutaneous injection, offering a targeted delivery method that may enhance its efficacy and reduce side effects compared to oral medications.
What evidence suggests that this trial's treatments could be effective for obesity and type 2 diabetes?
Research has shown that petrelintide, a long-lasting hormone, may aid in weight loss. In previous studies, participants using petrelintide lost up to 8.6% of their body weight, while those taking a placebo lost about 1.7%. The treatment also reduced waist size, with women experiencing particularly good results. This suggests petrelintide could be effective for individuals with obesity or type 2 diabetes seeking weight loss.46789
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly subcutaneous injections of petrelintide or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Petrelintide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zealand Pharma
Lead Sponsor
Parexel
Industry Sponsor
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