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

Launched by ZEALAND PHARMA · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called petrelintide to see how well it can help people with obesity or those who are overweight and have health issues, such as high blood pressure or cholesterol problems. The goal is to compare different doses of petrelintide to a placebo (a treatment that has no active ingredients) to understand its effects on weight, safety, and how well people tolerate it. The trial is currently looking for participants aged 65 to 74, who have a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with at least one health condition like hypertension or dyslipidemia.

To join the trial, participants need to meet certain criteria, including the ability to manage their own medication with a syringe. However, some individuals may not qualify due to health issues like diabetes, recent significant weight changes, or certain medical conditions. Participants in the trial will receive either the medication or the placebo once a week, and they will be monitored closely throughout the study. This is an important opportunity to help researchers learn more about new treatments for obesity and improve health outcomes for those affected.

Gender

ALL

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.