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New obesity drug AMG 513 enters first human tests

NCT ID NCT06585462

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called AMG 513 in 80 adults with obesity. The main goal is to see if the drug is safe and how the body handles it. Participants will receive either the drug or a placebo by injection, and researchers will monitor for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AMG 513
What this could lead to
If successful, this could lead to a new treatment option for obesity, helping people manage their weight.
What could go wrong
This is a very early Phase 1 trial with only 80 people, so it is primarily checking safety. The drug may not work for weight loss or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

82 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiometabolic disease

Contacts and locations

Locations

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida, 32256, United States

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33172, United States

  • Fomat Medical Research

    Oxnard, California, 93030, United States

  • Lillestol Research LLC

    Fargo, North Dakota, 58104, United States

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Pinnacle Clinical Research

    Austin, Texas, 78757, United States

  • Prime Health and Wellness Sky Clinical Research Network Group

    Fayette, Mississippi, 39069, United States

  • Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

    Union City, Georgia, 30291, United States

  • South Florida Clinical Research Institute - Lauderhill

    Lauderhill, Florida, 33351, United States

  • Translational Clinical Research LLC

    Aventura, Florida, 33180, United States

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