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

NCT ID: NCT06970405

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-29
• Study Completion Date: 2026-06-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High Dose

Randomized per the protocol

Group Type: EXPERIMENTAL

Garetosmab

Intervention Type: DRUG

Administered per the protocol

Low Dose

Randomized per the protocol

Group Type: EXPERIMENTAL

Garetosmab

Intervention Type: DRUG

Administered per the protocol

Placebo

Randomized per the protocol

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

Administered per the protocol

Interventions

Garetosmab

Administered per the protocol

Intervention Type: DRUG

Matching Placebo

Administered per the protocol

Intervention Type: DRUG

Other Intervention Names

REGN2477

Eligibility Criteria

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Other Identifiers

R2477-OB-2470

Identifier Type: -

Identifier Source: org_study_id