DRUG
Petrelintide
Petrelintide will be administered subcutaneously to participants once weekly
Status
Not yet recruiting
Phase
Phase 2
Enrollment
486
Locations
0
Results
Not posted
Publications
0
Study summary
The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.
Interventions
DRUG
Petrelintide will be administered subcutaneously to participants once weekly
COMBINATION_PRODUCT
Enicepatide will be administered subcutaneously to participants once weekly
DRUG
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
COMBINATION_PRODUCT
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
Timeline
First posted
May 15, 2026
Study start
Sep 30, 2026
Primary completion
Nov 12, 2027
Study completion
Jan 31, 2028
Results posted
Not reported
Registry updated
Jul 7, 2026
Outcomes
Percentage Change in Body Weight between Arms 1 and 6
Time frame · From Baseline to Week 40
Percentage Change in Body Weight between Arms 2, 3 and Arm 6
Time frame · From Baseline to Week 40
Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5
Time frame · From Baseline to Week 40
Percentage of Participants Achieving Body Weight Loss
Time frame · From Baseline to Week 40
Change in Body Weight (kilograms [kg])
Time frame · From Baseline to Week 40
Change in Body Mass Index (kilograms per square meter [kg/m²])
Time frame · From Baseline to Week 40
Change in Waist Circumference (centimeter [cm])
Time frame · From Baseline to Week 40
Change in Hemoglobin A1c (HbA1c) (percentage-points)
Time frame · From Baseline to Week 40
Change in Fasting Insulin
Time frame · From Baseline to Week 40
Change in Fasting Glucose
Time frame · From Baseline to Week 40
Change in Systolic Blood Pressure
Time frame · From Baseline to Week 40
Eligibility
Key Inclusion Criteria: * Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to \< 30 kg/m² with at least one weight-related comorbidity * History of at least one self-reported unsuccessful dietary effort to lose body weight Key Exclusion Criteria: * HbA1c ≥ 48 mmol/mol (6.5%) at screening * History of Type 1 or Type 2 Diabetes * Self-reported change in body weight \> 5 kg within 90 days prior to screening * Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed \> 1 year prior to or during screening) * Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner) * Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening * Current or previous treatment with petrelintide or any other amylin analog * Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity * History of severe psychiatric disorders * History of any hematologic conditions that may interfere with HbA1c measurement * Known history or presence of pancreatitis * Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility * New York Heart Association Functional Classification IV heart failure * Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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