Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
- 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.
- Acronym
- ZUPREME
- Short title
- Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbidities
- Official title
- A Randomized, Double-blind, Phase 2, Dose-finding Trial of Once Weekly Petrelintide Compared With Placebo in Participants With Obesity or Overweight With Weight Related Comorbidities
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-03-07
- First posted
- 2024-10-29
- Registry last updated
- 2026-03-23
- Primary completion date
- 2025-09-30
- Start date
- 2024-12-09
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Zealand Pharma
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06662539
- ClinicalTrials.gov ID
- NCT06662539
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent change from baseline in body weight to Week 28
Timeframe: From Baseline (Day 1) 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.
Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42
Timeframe: From Baseline (Day 1) to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42
Timeframe: From Baseline (Day 1) to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Change from baseline in body weight to Weeks 28 and 42
Timeframe: From Baseline (Day 1) to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Change from baseline in waist circumference to Weeks 28 and 42
Timeframe: From Baseline (Day 1) to Weeks 28 and 42
To compare the efficacy of petrelintide versus placebo on waist circumference, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Percent change from baseline in body weight to Week 42
Timeframe: From Baseline (Day 1) to Week 42
To compare the efficacy of petrelintide versus placebo on body weight, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Change from baseline in hemoglobin A1c (HbA1c) to Week 42
Timeframe: From Baseline (Day 1) to Week 42
To compare the efficacy of petrelintide versus placebo on HbA1c, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Change from baseline in fasting glucose to Week 42
Timeframe: From Baseline (Day 1) to Week 42
To compare the efficacy of petrelintide versus placebo on fasting glucose, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42
Timeframe: From Baseline (Day 1) to Week 42
To compare the efficacy of petrelintide versus placebo on hsCRP, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Change from baseline in fasting lipids to Week 42
Timeframe: From Baseline (Day 1) to Week 42
To compare the efficacy of petrelintide versus placebo on fasting lipids, when added as an adjunct to a reduced-calorie diet and increased physical activity.
Number of treatment emergent adverse events (TEAEs)
Timeframe: From Baseline (Day 1) to Week 51
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
Occurrences of anti-drug antibodies (ADAs) to petrelintide
Timeframe: From Baseline (Day 1) to Week 51
To compare the safety and tolerability of petrelintide versus placebo when added as an adjunct to a reduced-calorie diet and increased physical activity.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
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.
- 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.
- Known or suspected hypersensitivity to amylin analogs or related products.
- History of malignant neoplasms (except for basal or squamous cell skin cancer) within 5 years prior to screening.
- Known or suspected abuse of alcohol or recreational drugs.
- Participant previously treated with petrelintide or any other amylin analog.
- University of Alabama at BirminghamBirmingham, United States
- Excel Medical Clinical Trials, LLCBoca Raton, United States
- Innovative Research of West Florida, Inc.Clearwater, United States
- Century Research LLCMiami, United States
- Clinical Research Center of FloridaPompano Beach, United States
- Palm Beach Research CenterWest Palm Beach, United States
- Great Lakes Clinical Trials LLC dba Flourish ResearchChicago, United States
- AMR Wichita EastWichita, United States
- Alliance For Multispecialty Research, LLCLexington, United States
- Mercury Street Medical Group, PLLCButte, United States
- CHEAR Center LLCThe Bronx, United States
- Javara IncCharlotte, United States
- PharmQuest Life Sciences, LLCGreensboro, United States
- Lucas Research, Inc.New Bern, United States
- AMR NormanNorman, United States
- Altoona Center for Clinical Research - ResearchDuncansville, United States
- Alliance for Multispecialty ResearchKnoxville, United States
- Clinical Trials of Texas, LLC., dba Flourish ResearchSan Antonio, United States
- Manaasas Clinical Research CenterManassas, United States
- Krakowskie Centrum MedyczneSp.z o.oKrakow, Poland
- ETG SiedlceSiedlce, Poland
- FutureMeds Warszawa CentrumWarsaw, Poland
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i AdministracjiWarsaw, Poland
- ETG WarszawaWarsaw, Poland
- FutureMeds TargowekWarsaw, Poland
And 7 more, listed on the interactive page.
Other registry identifiers
- 2024-512549-18
Related records
Drugs (1)
Collaborators (1)
- Parexel
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition