Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Cardiometabolic Disease

Treatments: Drug: Placebo; Drug: AMG 513

Study type: Interventional

Funder types: Industry

Identifiers

NCT06585462

20230022

Details and patient eligibility

About

The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants will be male or female 18 to 65 years of age at the time of randomization with a body mass index (BMI) between ≥ 30 kg/m^2 and ≤ 40 kg/m^2.
• Females must be of non-reproductive potential.

Exclusion criteria

• History and/or clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and/or a fasting glucose of ≥ 126 mg/dL (7 mmol/L) at screening.
• Triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Single Ascending Dose (SAD) in Participants with Obesity (Part A)

Experimental group

Description:

In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).

Treatment:

Drug: AMG 513

Drug: Placebo

Multiple Ascending Dose (MAD) in Participants with Obesity (Part B)

Experimental group

Description:

In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.

Treatment:

Drug: AMG 513

Drug: Placebo