Clinical trial NCT06662539: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Keywords: Weight management
Amylin analog
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2024-10-29
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Obesity is a chronic disease with a rapidly increasing prevalence associated with significant comorbidities. Petrelintide is a long-acting amylin analog in development for weight management.

This is a randomized, double-blind, placebo-controlled, parallel-group, multinational, multicenter, dose-finding, Phase 2 clinical trial. The trial will compare 5 doses of once-weekly (OW) subcutaneously administered petrelintide with placebo.

This study consists of 3 periods:

1. A screening period of 2-3 weeks
2. A treatment period of 42 weeks
3. A safety follow-up period of 9 weeks.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent change from baseline in body weight to Week 28
timeFrame: From Baseline (Day 1) to Week 28
Secondary outcomes:
measure: Percentage of Participants achieving ≥5% Body Weight Loss at Weeks 28 and 42
timeFrame: From Baseline (Day 1) to Weeks 28 and 42
measure: Percentage of Participants achieving ≥10% Body Weight Loss at Weeks 28 and 42
timeFrame: From Baseline (Day 1) to Weeks 28 and 42
measure: Change from baseline in body weight to Weeks 28 and 42
timeFrame: From Baseline (Day 1) to Weeks 28 and 42
measure: Change from baseline in waist circumference to Weeks 28 and 42
timeFrame: From Baseline (Day 1) to Weeks 28 and 42
measure: Percent change from baseline in body weight to Week 42
timeFrame: From Baseline (Day 1) to Week 42
measure: Change from baseline in hemoglobin A1c (HbA1c) to Week 42
timeFrame: From Baseline (Day 1) to Week 42
measure: Change from baseline in fasting glucose to Week 42
timeFrame: From Baseline (Day 1) to Week 42
measure: Change from baseline in high-sensitivity C-reactive protein (hsCRP) to Week 42
timeFrame: From Baseline (Day 1) to Week 42
measure: Change from baseline in fasting lipids to Week 42
timeFrame: From Baseline (Day 1) to Week 42
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From Baseline (Day 1) to Week 51
measure: Occurrences of anti-drug antibodies (ADAs) to petrelintide
timeFrame: From Baseline (Day 1) to Week 51
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Century Research LLC
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials LLC dba Flourish Research
state: Illinois
city: Wichita
country: United States
facility: AMR Wichita East
state: Kansas
city: Lexington
country: United States
facility: Alliance For Multispecialty Research, LLC
state: Kentucky
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Bronx
country: United States
facility: CHEAR Center LLC
state: New York
city: Charlotte
country: United States
facility: Javara Inc
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences, LLC
state: North Carolina
city: New Bern
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Norman
country: United States
facility: AMR Norman
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research - Research
state: Pennsylvania
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC., dba Flourish Research
state: Texas
city: Manassas
country: United States
facility: Manaasas Clinical Research Center
state: Virginia
city: Krakow
country: Poland
facility: Krakowskie Centrum MedyczneSp.z o.o
state: Malopolskie
city: Siedlce
country: Poland
facility: ETG Siedlce
state: Mazowieckie
city: Warszawa
country: Poland
facility: FutureMeds Warszawa Centrum
state: Mazowieckie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
state: Mazowieckie
city: Warszawa
country: Poland
facility: ETG Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: FutureMeds Targowek
state: Mazowieckie
city: Olsztyn
country: Poland
facility: Futuremeds Olsztyn
state: Warminsko-mazurskie
city: Craiova
country: Romania
facility: Top Diabet
state: Dolj
city: Bucuresti
country: Romania
facility: Institutul National de Endocrinologie C I Parhon
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Fundatia Dr Victor Babes
city: Bucuresti
country: Romania
facility: Institutul De Pneumoftiziologie Marius Nasta
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei Constanta
Study officials:
References: