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

Regeneron Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: Matching Placebo; Drug: Garetosmab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06970405

R2477-OB-2470

Details and patient eligibility

About

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)

Enrollment: 48 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 3 patient groups, including a placebo group

High Dose

Experimental group

Description:

Randomized per the protocol

Treatment:

Drug: Garetosmab

Low Dose

Experimental group

Description:

Randomized per the protocol

Treatment:

Drug: Garetosmab

Placebo

Placebo Comparator group

Description:

Randomized per the protocol

Treatment:

Drug: Matching Placebo