Status:
WITHDRAWN
Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief Summary
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity. The aim of the study is to see how ...
Eligibility Criteria
Inclusion
- Key
- Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol
- Women must be postmenopausal, as defined in the protocol
- Serum testosterone within age-adjusted normal range for men at screening
- The platelet count is within the normal lower and upper laboratory range
- Key
Exclusion
- Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol
- History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol
- History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol
- 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
- Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol
- 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
- 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
- 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
Key Trial Info
Start Date :
May 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06970405
Start Date
May 29 2025
End Date
June 8 2026
Last Update
September 17 2025
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