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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment A: Petrelintide Dose 1 		Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1.
  • Drug: Petrelintide
    Petrelintide will be taken by participants once weekly subcutaneously.
    Other names:
    • ZP8396
Placebo Comparator
Treatment B: Petrelintide Placebo Dose 1 		Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
  • Other: Placebo
    Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Experimental
Treatment C: Petrelintide Dose 2 		Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2.
  • Drug: Petrelintide
    Petrelintide will be taken by participants once weekly subcutaneously.
    Other names:
    • ZP8396
Placebo Comparator
Treatment D: Petrelintide Placebo Dose 2 		Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
  • Other: Placebo
    Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.
Experimental
Treatment E: Petrelintide Dose 3 		Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3.
  • Drug: Petrelintide
    Petrelintide will be taken by participants once weekly subcutaneously.
    Other names:
    • ZP8396
Placebo Comparator
Treatment F: Petrelintide Placebo Dose 3 		Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide.
  • Other: Placebo
    Matching placebo to petrelintide will be taken by participants once weekly subcutaneously.

Recruiting Locations

Cullman Clinical Trials - Family Medicine
Cullman 4057835, Alabama 4829764 35055

Elite Clinical Studies, LLC
Phoenix 5308655, Arizona 5551752 85018

Medical Investigation Inc
Little Rock 4119403, Arkansas 4099753 72211-1847

Velocity Clinical Research
Huntington Park 5358736, California 5332921 90255

Diablo Clinical Research Inc.
Walnut Creek 5406990, California 5332921 94598

Chase Medical Research, LLC
Waterbury 4845193, Connecticut 4831725 06708

Innovative Research of West Florida
Clearwater 4151316, Florida 4155751 33756

East Coast Institute for Research, LLC
Jacksonville 4160021, Florida 4155751 32204

Solutions Through Advanced Research, Inc
Jacksonville 4160021, Florida 4155751 32216

West Orange Endocrinology P.A
Ocoee 4166776, Florida 4155751 34761

East Coast Institute for Research - Canton
Canton 4186213, Georgia 4197000 30114

Iowa Diabetes & Endocrinology Research Center
West Des Moines 4881346, Iowa 4862182 50266

DelRicht Research - New Orleans
New Orleans 4335045, Louisiana 4331987 70115

AAMRC
Flint 4992982, Michigan 5001836 48504

International Diabetes Center
Minneapolis 5037649, Minnesota 5037779 55416

Mercury Street Medical Group, PLLC
Butte 5642934, Montana 5667009 59701

Palm Research Center, Inc.
Las Vegas 5506956, Nevada 5509151 89148

PharmQuest Life Sciences, LLC
Greensboro 4469146, North Carolina 4482348 27408

Lynn Institute of Norman
Norman 4543762, Oklahoma 4544379 73072

Elligo Clinical Research, Inc.
Austin 4671654, Texas 4736286 78704

The University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390-8857

Juno Research LLC
Houston 4699066, Texas 4736286 77040

Consano Clinical Research
Shavano Park 4728147, Texas 4736286 78231

Manaasas Clinical Research Center
Manassas 4771401, Virginia 6254928 20110

More Details

NCT ID
NCT06926842
Status
Recruiting
Sponsor
Zealand Pharma

Study Contact

Zealand Pharma
+45 8877 3600
clinicaltrials@zealandpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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