Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women

Launched by REGENERON PHARMACEUTICALS · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called garetosmab to see how safe it is for healthy people who are obese, specifically focusing on men and post-menopausal women. Researchers want to understand how the drug affects blood levels, hormone levels, and whether the body reacts to the drug in any way. The goal is to gather important information on how well the drug works and what side effects it might cause.

To participate in this study, you need to be an adult with obesity (a body mass index of 30 or higher) and otherwise healthy. Women must be post-menopausal, and men should have normal testosterone levels. However, certain people are not eligible, including those with diabetes, certain bleeding disorders, or significant health issues like heart or kidney disease. If you choose to join, you can expect regular check-ups and tests to monitor how the drug is affecting you and your body. This trial is not yet recruiting participants, but it aims to gather vital information that could help in developing new treatments for obesity.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol
• • 2. Women must be postmenopausal, as defined in the protocol
• • 3. Serum testosterone within age-adjusted normal range for men at screening
• • 4. The platelet count is within the normal lower and upper laboratory range
• Key Exclusion Criteria:
• • 1. Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol
• • 2. History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol
• • 3. History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol
• • 4. Any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease
• • 5. Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol
• • 6. Antiplatelet therapy (eg clopidogrel, aspirin), anticoagulants (eg, warfarin, heparin, factor Xa inhibitor, or thrombin inhibitors) in the last 90 days or within 5 half-lives of the therapy at screening, whichever is longer
• • 7. Use in the previous 90 days for \>7 consecutive days at screening of anti-obesity medications, anabolic agents, systemic steroids, androgens, estrogens, or progestogens. Chronic stable doses of thyroid hormones in participants with normal thyroid function are allowed
• • 8. For women, current use, or past use in the last 90 days at screening of hormonal replacement or contraceptive therapy
• • NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply