Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
- Registration Number
- NCT06970405
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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 safe and tolerable the study drug is.
The study is looking at several other research questions, including:
* How much study drug is in the blood at different times
* What effect the study drug has on the blood clotting
* What effect the study drug has on hormone levels
* What effect the study drug has on some organs that produce hormones
* What effect hormones have on the side effects produced by the study drug
* Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose Garetosmab Randomized per the protocol Low Dose Garetosmab Randomized per the protocol Placebo Matching Placebo Randomized per the protocol
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) Through Week 32 Severity of TEAEs Through Week 32
- Secondary Outcome Measures
Name Time Method Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum FSH level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum Luteinizing Hormone (LH) level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum LH level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum total testosterone level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum total testosterone level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum free testosterone level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum free testosterone level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum estradiol level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum estradiol level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum 17-OHP level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum DHEA-S level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in serum androstenedione level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Percent change in serum androstenedione level in response to GnRH injection Pre-GnRH Baseline, Through Week 20 Post-GnRH Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection Pre-ACTH Baseline, Through Week 20 post-ACTH Percent change in cortisol level in response to ACTH injection Pre-ACTH Baseline, Through Week 20 post-ACTH Concentrations of garetosmab in serum Through Week 32 Concentrations of total activin A in serum Through Week 32 Change in bleeding time Baseline, At Week 8 Percent change in bleeding time Baseline, At Week 8 Change in thrombin time Baseline, At Week 8 Percent change in thrombin time Baseline, At Week 8 Change in Activated Partial Thromboplastin Time (aPTT) Baseline, At Week 8 Percent change in aPTT Baseline, At Week 8 Change in Prothrombin Time (PT) Baseline, At Week 8 Percent change in PT Baseline, At Week 8 Change in International Normalized Ratio (INR) Baseline, At Week 8 Percent change in INR Baseline, At Week 8 Change in platelets count Baseline, At Week 8 Percent change in platelets count Baseline, At Week 8 Change in serum ACTH level Baseline, Through Week 20 Percent change in serum ACTH level Baseline, Through Week 20 Change in serum FSH level Baseline, Through Week 20 Percent change in serum FSH level Baseline, Through Week 20 Change in serum LH level Baseline, Through Week 20 Percent change in serum LH level Baseline, Through Week 20 Change in serum Thyroid Stimulating Hormone (TSH) level Baseline, Through Week 20 Percent change in serum TSH level Baseline, Through Week 20 Change in serum Thyroxine (T4) level Baseline, Through Week 20 Percent change in serum T4 level Baseline, Through Week 20 Change in serum total testosterone level Baseline, Through Week 20 Percent change in serum total testosterone level Baseline, Through Week 20 Change in serum free testosterone level Baseline, Through Week 20 Percent change in serum free testosterone level Baseline, Through Week 20 Change in serum 17-OHP level Baseline, Through Week 20 Percent change in serum 17-OHP level Baseline, Through Week 20 Change in serum estradiol level Baseline, Through Week 20 Percent change in serum estradiol level Baseline, Through Week 20 Change in serum DHEA-S level Baseline, Through Week 20 Percent change in serum DHEA-S level Baseline, Through Week 20 Change in serum androstenedione level Baseline, Through Week 20 Percent change in serum androstenedione level Baseline, Through Week 20 Change in serum Human Growth Hormone (HGH) level Baseline, Through Week 20 Percent change in serum HGH level Baseline, Through Week 20 Change in serum Insulin-like Growth Factor (IGF)-1 level Baseline, Through Week 20 Percent change in serum IGF-1 level Baseline, Through Week 20 Change in serum cortisol level Baseline, Through Week 20 Percent change in serum cortisol level Baseline, Through Week 20 Incidence of Anti-Drug Antibodies (ADA) to garetosmab Through Week 32 Titer of ADA to garetosmab Through Week 32