A Phase 2 interventional study of Petrelintide and Placebo in Overweight, Type 2 Diabetes and Obesity, sponsored by Zealand Pharma. Completed at 48 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Zealand Pharma · Phase 2, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 221 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
Drug: Petrelintide
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Other: Placebo
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
Drug: Petrelintide
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Other: Placebo
Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
Drug: Petrelintide
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
Other: Placebo
Petrelintide will be taken by participants once weekly subcutaneously.
Also known as: ZP8396
Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Percentage Change in Body Weight
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥5% Body Weight Loss
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≥10% Body Weight Loss
Time frame: From Baseline (Day 1) to Weeks 28
Change in Body Weight (kilogram)
Time frame: From Baseline (Day 1) to Weeks 28
Change in Waist Circumference
Time frame: From Baseline (Day 1) to Weeks 28
Change in Glycated Hemoglobin (HbA1c)
Time frame: From Baseline (Day 1) to Weeks 28
Change in Fasting Glucose
Time frame: From Baseline (Day 1) to Weeks 28
Change in High-Sensitivity C-reactive protein (hsCRP)
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants Achieving ≤6.5% HbA1c
Time frame: From Baseline (Day 1) to Weeks 28
Changes in Fasting Lipids
Time frame: From Baseline (Day 1) to Weeks 28
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Baseline (Day 1) to Weeks 38
Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38
Time frame: From Baseline (Day 1) to Weeks 38
Number of Participants with Positive Anti-Drug Antibodies (ADAs)
Time frame: From Baseline (Day 1) to Weeks 38
Change in Systolic Blood Pressure
Time frame: From Baseline (Day 1) to Week 38
Change in Diastolic Blood Pressure
Time frame: From Baseline (Day 1) to Week 38
Change in Pulse Rate
Time frame: From Baseline (Day 1) to Week 38
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Petrelintide