Sponsor Decision

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)

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

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

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

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