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

Conditions

• Cardiometabolic Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• AMG 513 — DRUG
  AMG 513 will be administered by SC or IV injection.
• Placebo — DRUG
  Placebo will be administered by SC or IV injection.
• AMG 513 — DRUG
  AMG 513 will be administered by SC injection.
• Placebo — DRUG
  Placebo will be administered by SC injection.

Study Details

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

Key Dates

Start date

Sep 9, 2024

Status verified

Jun 2026

Primary completion

Oct 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Single Ascending Dose (SAD) in Participants with Obesity (Part A)
  In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).
• Experimental: Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B)
  In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAE) [ Time Frame: Approximately 178 days (Part A) and 225 days (Part B) ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (7)

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