Testing new protein-based tablets in healthy men

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants

This study is testing four different types of semaglutide tablets in healthy men to see how well each one is absorbed by the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 64 Years
• Sex: Male
• Sponsor: Novo Nordisk A/S (industry)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06642584 on ClinicalTrials.gov

What this trial studies

This study compares four different formulations of semaglutide tablets to evaluate how each version is absorbed in the body. Healthy male participants aged 18 to 64 with a BMI between 22.0 and 31.9 kg/m² will be randomly assigned to receive one of the tablet versions. The study will last approximately 28 weeks and aims to assess the safety and efficacy of these formulations. Participants will undergo medical evaluations to ensure they meet health criteria before enrollment.

Who should consider this trial

Good fit: Ideal candidates are healthy males aged 18-64 with a specific BMI range.

Not a fit: Patients with known hypersensitivity to the study medications or those with certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved oral formulations of semaglutide for managing Type 2 diabetes.

How similar studies have performed: Other studies have shown promise with similar formulations of semaglutide, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male.
2. Age 18-64 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
4. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

1. Known or suspected hypersensitivity to study interventions or related products.
2. Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to first dosing.

Where this trial is running

Montreal, Quebec

• Altasciences — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Novo Nordisk

Conditions: Healthy Volunteers Type 2 Diabetes