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

NCT06970405 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: R2477-OB-2470
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Obesity

Keywords

Healthy; Postmenopausal

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (TEAEs)

  Through Week 32

• Severity of TEAEs

  Through Week 32

Secondary Outcomes (62)

• 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

Study Arms (3)

High Dose

EXPERIMENTAL

Randomized per the protocol

Drug: Garetosmab

Low Dose

EXPERIMENTAL

Randomized per the protocol

Drug: Garetosmab

Placebo

PLACEBO COMPARATOR

Randomized per the protocol

Drug: Matching Placebo

Interventions

Garetosmab DRUG

Administered per the protocol

Also known as: REGN2477

High Dose; Low Dose

Matching Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): June 8, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf