Clinical trial NCT06970405: Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Obesity
Keywords: Healthy
Postmenopausal
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Through Week 32
measure: Severity of TEAEs
timeFrame: Through Week 32
Secondary outcomes:
measure: Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum FSH level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum Luteinizing Hormone (LH) level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum LH level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum total testosterone level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum total testosterone level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum free testosterone level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum free testosterone level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum estradiol level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum estradiol level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum 17-OHP level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum DHEA-S level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in serum androstenedione level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Percent change in serum androstenedione level in response to GnRH injection
timeFrame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
measure: Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection
timeFrame: Pre-ACTH Baseline, Through Week 20 post-ACTH
measure: Percent change in cortisol level in response to ACTH injection
timeFrame: Pre-ACTH Baseline, Through Week 20 post-ACTH
measure: Concentrations of garetosmab in serum
timeFrame: Through Week 32
measure: Concentrations of total activin A in serum
timeFrame: Through Week 32
measure: Change in bleeding time
timeFrame: Baseline, At Week 8
measure: Percent change in bleeding time
timeFrame: Baseline, At Week 8
measure: Change in thrombin time
timeFrame: Baseline, At Week 8
measure: Percent change in thrombin time
timeFrame: Baseline, At Week 8
measure: Change in Activated Partial Thromboplastin Time (aPTT)
timeFrame: Baseline, At Week 8
measure: Percent change in aPTT
timeFrame: Baseline, At Week 8
measure: Change in Prothrombin Time (PT)
timeFrame: Baseline, At Week 8
measure: Percent change in PT
timeFrame: Baseline, At Week 8
measure: Change in International Normalized Ratio (INR)
timeFrame: Baseline, At Week 8
measure: Percent change in INR
timeFrame: Baseline, At Week 8
measure: Change in platelets count
timeFrame: Baseline, At Week 8
measure: Percent change in platelets count
timeFrame: Baseline, At Week 8
measure: Change in serum ACTH level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum ACTH level
timeFrame: Baseline, Through Week 20
measure: Change in serum FSH level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum FSH level
timeFrame: Baseline, Through Week 20
measure: Change in serum LH level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum LH level
timeFrame: Baseline, Through Week 20
measure: Change in serum Thyroid Stimulating Hormone (TSH) level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum TSH level
timeFrame: Baseline, Through Week 20
measure: Change in serum Thyroxine (T4) level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum T4 level
timeFrame: Baseline, Through Week 20
measure: Change in serum total testosterone level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum total testosterone level
timeFrame: Baseline, Through Week 20
measure: Change in serum free testosterone level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum free testosterone level
timeFrame: Baseline, Through Week 20
measure: Change in serum 17-OHP level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum 17-OHP level
timeFrame: Baseline, Through Week 20
measure: Change in serum estradiol level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum estradiol level
timeFrame: Baseline, Through Week 20
measure: Change in serum DHEA-S level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum DHEA-S level
timeFrame: Baseline, Through Week 20
measure: Change in serum androstenedione level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum androstenedione level
timeFrame: Baseline, Through Week 20
measure: Change in serum Human Growth Hormone (HGH) level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum HGH level
timeFrame: Baseline, Through Week 20
measure: Change in serum Insulin-like Growth Factor (IGF)-1 level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum IGF-1 level
timeFrame: Baseline, Through Week 20
measure: Change in serum cortisol level
timeFrame: Baseline, Through Week 20
measure: Percent change in serum cortisol level
timeFrame: Baseline, Through Week 20
measure: Incidence of Anti-Drug Antibodies (ADA) to garetosmab
timeFrame: Through Week 32
measure: Titer of ADA to garetosmab
timeFrame: Through Week 32
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: