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

NCT06585462 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20230022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Cardiometabolic Disease

Keywords

AMG 513; Cardiometabolic disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAE)

  Approximately 178 days (Part A) and 225 days (Part B)

Secondary Outcomes (3)

• Maximum Observed Drug Concentration (Cmax) of AMG 513

  Day 1 up to Day 57

• Time to Cmax (Tmax) of AMG 513

  Day 1 up to Day 57

• Area Under the Concentration-time Curve (AUC) of AMG 513

  Day 1 up to Day 57

Study Arms (2)

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

EXPERIMENTAL

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

Drug: AMG 513; Drug: Placebo

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

EXPERIMENTAL

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

Drug: AMG 513; Drug: Placebo

Interventions

AMG 513 DRUG

AMG 513 will be administered by SC or IV injection.

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

Placebo DRUG

Placebo will be administered by SC or IV injection.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg/m\^2 to 40.0 kg/m\^2 for Part A and BMI of 27.0 kg/m\^2 to 40.0 kg/m\^2 for Part B.
• Females enrolled must be of non-childbearing potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

RECRUITING

Carilion Medical Center

Lake Forest, California, 92630, United States

RECRUITING

Fomat Medical Research

Oxnard, California, 93030, United States

RECRUITING

Translational Clinical Research LLC

Aventura, Florida, 33180, United States

RECRUITING

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33172, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (5)