Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities

NCT06662539 | Completed Phase 2 FDA Drug

• 2 other identifiers: ZP8396-230942024-512549-18
• Study Type: interventional
• Target: 493
• Locations: 3 countries
• Sites: 32

Brief Summary

The main purpose of this study is to compare dose levels of petrelintide versus placebo with regards to effect on body weight, safety, and tolerability.

Conditions

Obesity

Keywords

Weight management; Amylin analog

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in body weight to Week 28

  To compare the dose-response of increasing doses of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity after 28 weeks of exposure.

  From Baseline (Day 1) to Week 28

Secondary Outcomes (11)

• Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42

  From Baseline (Day 1) to Weeks 28 and 42

• Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42

  From Baseline (Day 1) to Weeks 28 and 42

• Change from baseline in body weight to Weeks 28 and 42

  From Baseline (Day 1) to Weeks 28 and 42

• Change from baseline in waist circumference to Weeks 28 and 42

  From Baseline (Day 1) to Weeks 28 and 42

• Percent change from baseline in body weight to Week 42

  From Baseline (Day 1) to Week 42

Study Arms (6)

Petrelintide Dose 1

EXPERIMENTAL

Participants will self-inject petrelintide dose 1 subcutaneously once a week.

Drug: Petrelintide

Petrelintide Dose 2

EXPERIMENTAL

Participants will self-inject petrelintide dose 2 subcutaneously once a week.

Drug: Petrelintide

Petrelintide Dose 3

EXPERIMENTAL

Participants will self-inject petrelintide dose 3 subcutaneously once a week.

Drug: Petrelintide

Petrelintide Dose 4

EXPERIMENTAL

Participants will self-inject petrelintide dose 4 subcutaneously once a week.

Drug: Petrelintide

Petrelintide Dose 5

EXPERIMENTAL

Participants will self-inject petrelintide dose 5 subcutaneously once a week.

Drug: Petrelintide

Placebo

PLACEBO COMPARATOR

Participants will self-inject matching placebo to petrelintide subcutaneously once a week.

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo to petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.

Placebo

Petrelintide DRUG

Petrelintide will be taken by participants once weekly as a self-administered subcutaneous injection.

Also known as: ZP8396

Petrelintide Dose 1; Petrelintide Dose 2; Petrelintide Dose 3; Petrelintide Dose 4; Petrelintide Dose 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants having body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of at least one of the following comorbidities: hypertension or dyslipidemia (treated or untreated).
• A female participant is eligible to participate if she is:
• A woman of nonchildbearing potential. OR
• A woman of childbearing potential (WOCBP) who is not pregnant, does not intend to be pregnant, not lactating and is willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial and for 10 weeks after the last injection of the investigational medicinal product (IMP).
• Ability to comply with the protocol requirements including self-administration of IMP with vial and syringe.

You may not qualify if:

• Glycated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%), as measured at screening.
• History of type 1 or type 2 diabetes mellitus.
• Treatment with glucose lowering agent(s) within 90 days prior to screening.
• A self-reported change in body weight \>5% within 90 days prior to screening.
• 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.
• Uncontrolled thyroid disease defined as thyroid stimulating hormone \>4.20 mIU/L or \<0.27 mIU/L as measured by the central laboratory at screening.
• Lifetime history of a suicidal attempt.
• History of major depressive disorder or other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
• Estimated glomerular filtration rate value \<60.0 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation17, measured at screening.
• Impaired liver function, defined as alanine aminotransferase and/or aspartate aminotransferase ≥2.0 times or bilirubin \>1.5 times upper normal limit, measured at screening.
• Presence or history of acute or chronic pancreatitis.
• Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic treatment that affects gastrointestinal (GI) motility.
• Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation.
• Presence or history of clinically significant arrhythmias or clinically significant conduction disorders.

Sponsors & Collaborators

• Parexel: collaborator
• Zealand Pharma: lead

Study Sites (32)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Excel Medical Clinical Trials, LLC

Boca Raton, Florida, 33434, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Century Research LLC

Miami, Florida, 33155, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060-6977, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Great Lakes Clinical Trials LLC dba Flourish Research

Chicago, Illinois, 60640, United States

Location

AMR Wichita East

Wichita, Kansas, 67226, United States

Location

Alliance For Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

CHEAR Center LLC

The Bronx, New York, 10455, United States

Location

Javara Inc

Charlotte, North Carolina, 28210, United States

Location

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, 27408, United States

Location

Lucas Research, Inc.

New Bern, North Carolina, 28562, United States

Location

AMR Norman

Norman, Oklahoma, 73069, United States

Location

Altoona Center for Clinical Research - Research

Duncansville, Pennsylvania, 16635, United States

Location

Alliance for Multispecialty Research

Knoxville, Tennessee, 37909, United States

Location

Clinical Trials of Texas, LLC., dba Flourish Research

San Antonio, Texas, 78229, United States

Location

Manaasas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Krakowskie Centrum MedyczneSp.z o.o

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

ETG Siedlce

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship, 00-215, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

ETG Warszawa

Warsaw, Masovian Voivodeship, 02-677, Poland

Location

FutureMeds Targowek

Warsaw, Masovian Voivodeship, 03-291, Poland

Location

Futuremeds Olsztyn

Olsztyn, Warmian-Masurian Voivodeship, 10-165, Poland

Location

Top Diabet

Craiova, Dolj, 200515, Romania

Location

Institutul National de Endocrinologie C I Parhon

Bucharest, 011863, Romania

Location

Institutul Clinic Fundeni

Bucharest, 022328, Romania

Location

Fundatia Dr Victor Babes

Bucharest, 030303, Romania

Location

Institutul De Pneumoftiziologie Marius Nasta

Bucharest, 050159, Romania

Location

Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei Constanta

Constanța, 900591, Romania

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: December 9, 2024
• Primary Completion: September 30, 2025
• Study Completion: March 7, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); RO (6); US (19)