Testing petrelintide for weight management in people with obesity and type 2 diabetes
A Randomized, Double-Blind, Phase 2 Trial of Once-Weekly Petrelintide Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes
PHASE2 · Zealand Pharma · NCT06926842
This study is testing if a new medication called petrelintide can help people with obesity and type 2 diabetes lose weight and manage their diabetes better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand Pharma (industry) |
| Locations | 25 sites (Cullman, Alabama and 24 other locations) |
| Trial ID | NCT06926842 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of three different doses of petrelintide, a long-acting amylin analogue, compared to a placebo in participants who are overweight or obese and have type 2 diabetes. Participants must have a stable treatment regimen with metformin and/or sodium-glucose cotransporter 2 inhibitors for at least 90 days prior to screening. The study aims to determine if petrelintide can effectively aid in weight management and improve diabetes control in this population.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI of 27.0 kg/m2 or higher who have been diagnosed with type 2 diabetes for at least 180 days.
Not a fit: Patients with a history of severe hypoglycemia, recent significant weight changes, or those undergoing other obesity treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for weight management and improved glycemic control in patients with type 2 diabetes.
How similar studies have performed: Other studies involving long-acting amylin analogues have shown promise, but this specific approach with petrelintide is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Main Inclusion Criteria: * Male or female participants with body mass index (BMI) ≥27.0 kg/m2. * Diagnosed with type 2 diabetes ≥180 days prior to the day of screening. * Treated with metformin with or without sodium-glucose cotransporter 2 inhibitors. Treatment should be stable (same drug\[s\], dose, and dosing frequency) for at least 90 days prior to screening. Main Exclusion Criteria: * Severe hypoglycemia within 6 months prior to screening or history of hypoglycemia unawareness. * Receipt of any other glucose-lowering drug than those listed in the inclusion criterion within 90 days prior to screening. * A self-reported change in body weight \>5% within 90 days prior to screening, irrespective of medical records. * Treatment with any medication (prescribed or over-the-counter) or alternative remedies (herbal or nutritional supplements) intended to promote weight loss within 6 months prior to screening. * Previous or planned (during the trial period) obesity treatment with surgery or a body weight loss device. However, liposuction or surgical removal of fat depots more than 1 year prior to screening or device-based interventions (e.g., sleeve, banding, or similar) that have been removed more than 6 months prior to screening, are allowed. * Obesity due to endocrine disorders or genetic syndromes.
Where this trial is running
Cullman, Alabama and 24 other locations
- Cullman Clinical Trials - Family Medicine — Cullman, Alabama, United States (NOT_YET_RECRUITING)
- Elite Clinical Studies, LLC — Phoenix, Arizona, United States (RECRUITING)
- Medical Investigation Inc — Little Rock, Arkansas, United States (NOT_YET_RECRUITING)
- AMCR Institute, Inc. — Escondido, California, United States (WITHDRAWN)
- Velocity Clinical Research — Huntington Park, California, United States (NOT_YET_RECRUITING)
- Diablo Clinical Research Inc. — Walnut Creek, California, United States (NOT_YET_RECRUITING)
- Chase Medical Research, LLC — Waterbury, Connecticut, United States (NOT_YET_RECRUITING)
- Innovative Research of West Florida — Clearwater, Florida, United States (RECRUITING)
- East Coast Institute for Research, LLC — Jacksonville, Florida, United States (NOT_YET_RECRUITING)
- Solutions Through Advanced Research, Inc — Jacksonville, Florida, United States (NOT_YET_RECRUITING)
- West Orange Endocrinology P.A — Ocoee, Florida, United States (RECRUITING)
- East Coast Institute for Research - Canton — Canton, Georgia, United States (NOT_YET_RECRUITING)
- Iowa Diabetes & Endocrinology Research Center — West Des Moines, Iowa, United States (NOT_YET_RECRUITING)
- DelRicht Research - New Orleans — New Orleans, Louisiana, United States (NOT_YET_RECRUITING)
- AAMRC — Flint, Michigan, United States (NOT_YET_RECRUITING)
- International Diabetes Center — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
- Mercury Street Medical Group, PLLC — Butte, Montana, United States (NOT_YET_RECRUITING)
- Palm Research Center, Inc. — Las Vegas, Nevada, United States (NOT_YET_RECRUITING)
- PharmQuest Life Sciences, LLC — Greensboro, North Carolina, United States (RECRUITING)
- Lynn Institute of Norman — Norman, Oklahoma, United States (NOT_YET_RECRUITING)
- Elligo Clinical Research, Inc. — Austin, Texas, United States (NOT_YET_RECRUITING)
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States (NOT_YET_RECRUITING)
- Juno Research LLC — Houston, Texas, United States (RECRUITING)
- Consano Clinical Research — Shavano Park, Texas, United States (RECRUITING)
- Manaasas Clinical Research Center — Manassas, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Zealand Pharma
- Email: clinicaltrials@zealandpharma.com
- Phone: +45 8877 3600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overweight, Type 2 Diabetes, Obesity, Long-acting amylin analogues, Weight management