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Monoclonal Antibodies

AMG 513 for Obesity

Phase 1
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Females must be of non-reproductive potential.
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to determine if AMG 513 is safe and well-tolerated when given as a single dose and multiple doses.

Who is the study for?
This trial is for men and women aged 18 to 65 with obesity, defined as having a BMI between ≥30 and ≤40. Women must be unable to bear children. It's not specified who can't join the trial.
What is being tested?
The study is testing AMG 513, a potential new treatment for obesity. Participants will receive either AMG 513 or a placebo without any active drug in it, to compare effects on safety and tolerability after one dose and several doses over time.
What are the potential side effects?
Since the goal is to assess safety, side effects are being closely monitored but aren't listed here. Common side effects of drugs like this could include digestive issues, headaches, fatigue, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I cannot become pregnant.
Select...
I am between 18 and 65 years old with a BMI of 30 to 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Ascending Dose (SAD) in Participants with Obesity (Part A)Experimental Treatment2 Interventions
In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).
Group II: Multiple Ascending Dose (MAD) in Participants with Obesity (Part B)Experimental Treatment2 Interventions
In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,359 Total Patients Enrolled
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
945,160 Total Patients Enrolled
~53 spots leftby Aug 2026
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