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

Regeneron Pharmaceuticals

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Obesity

Interventions

GaretosmabDRUG

Administered per the protocol

Matching PlaceboDRUG

Administered per the protocol

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time frame: Through Week 32

Severity of TEAEs

Time frame: Through Week 32

Secondary Outcomes

Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum FSH level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in serum Luteinizing Hormone (LH) level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum LH level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in serum total testosterone level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum total testosterone level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in serum free testosterone level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum free testosterone level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Data from ClinicalTrials.gov

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Change in serum estradiol level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum estradiol level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum 17-OHP level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum DHEA-S level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in serum androstenedione level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Percent change in serum androstenedione level in response to GnRH injection

Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH

Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection

Time frame: Pre-ACTH Baseline, Through Week 20 post-ACTH

Percent change in cortisol level in response to ACTH injection

Time frame: Pre-ACTH Baseline, Through Week 20 post-ACTH

Concentrations of garetosmab in serum

Time frame: Through Week 32

Concentrations of total activin A in serum

Time frame: Through Week 32

Change in bleeding time

Time frame: Baseline, At Week 8

Percent change in bleeding time

Time frame: Baseline, At Week 8

Change in thrombin time

Time frame: Baseline, At Week 8

Percent change in thrombin time

Time frame: Baseline, At Week 8

Change in Activated Partial Thromboplastin Time (aPTT)

Time frame: Baseline, At Week 8

Percent change in aPTT

Time frame: Baseline, At Week 8

Change in Prothrombin Time (PT)

Time frame: Baseline, At Week 8

Percent change in PT

Time frame: Baseline, At Week 8

Change in International Normalized Ratio (INR)

Time frame: Baseline, At Week 8

Percent change in INR

Time frame: Baseline, At Week 8

Change in platelets count

Time frame: Baseline, At Week 8

Percent change in platelets count

Time frame: Baseline, At Week 8

Change in serum ACTH level