Cardiometabolic DiseasePhase 1NCT06585462
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
A Phase 1 study testing AMG 513 in people with Cardiometabolic Disease, run by Amgen at 13 sites in United States.
Trial summary
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Disease
- What is being tested?
- AMG 513
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 13 sitesUnited States
- Study dates
- 9 Sep 2024to 16 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Pinnacle Clinical Research
Austin, Texas, 78757
Translational Clinical Research LLC
Aventura, Florida, 33180
Lillestol Research LLC
Fargo, North Dakota, 58104
Prime Health and Wellness Sky Clinical Research Network Group
Fayette, Mississippi, 39069
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256
Orange County Research Center
Lake Forest, California, 92630
South Florida Clinical Research Institute - Lauderhill
Lauderhill, Florida, 33351
New Horizon Research Center
Miami, Florida, 33165
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33172
Clinical Neuroscience Solutions
Orlando, Florida, 32801
Fomat Medical Research
Oxnard, California, 93030
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia, 30291
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
- Conditions
- Cardiometabolic Disease
- Being tested
- AMG 513, Placebo
- Keywords
- AMG 513, Cardiometabolic disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 513Drug
AMG 513 will be administered by SC or IV injection.
PlaceboDrug
Placebo will be administered by SC or IV injection.
AMG 513Drug
AMG 513 will be administered by SC injection.
PlaceboDrug
Placebo will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: AMG 513; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Measured: Day 1 up to approximately 150 days after last dose
Secondary outcomes (3)
Maximum Observed Drug Concentration (Cmax) of AMG 513
Measured: Day 1 up to approximately 150 days after last dose
Time to Cmax (Tmax) of AMG 513
Measured: Day 1 up to approximately 150 days after last dose
Area Under the Concentration-time Curve (AUC) of AMG 513
Measured: Day 1 up to approximately 150 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start9 Sep 2024
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585462
- Sponsor's protocol ID
- 20230022
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06585462
- Acronym / sponsor ID
- 20230022
- Conditions
- Cardiometabolic Disease
- Keywords
- AMG 513, Cardiometabolic disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) in Participants with Obesity (Part A) | Experimental | Drug: AMG 513, Drug: PlaceboIn Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV). |
| Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B) | Experimental | Drug: AMG 513, Drug: PlaceboIn Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 513AMG 513 will be administered by SC or IV injection. | Drug | Single Ascending Dose (SAD) in Participants with Obesity (Part A) |
| PlaceboPlacebo will be administered by SC or IV injection. | Drug | Single Ascending Dose (SAD) in Participants with Obesity (Part A) |
| AMG 513AMG 513 will be administered by SC injection. | Drug | Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B) |
| PlaceboPlacebo will be administered by SC injection. | Drug | Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B) |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: Day 1 up to approximately 150 days after last dose
3 secondary outcomes
Maximum Observed Drug Concentration (Cmax) of AMG 513
Time frame: Day 1 up to approximately 150 days after last dose
Time to Cmax (Tmax) of AMG 513
Time frame: Day 1 up to approximately 150 days after last dose
Area Under the Concentration-time Curve (AUC) of AMG 513
Time frame: Day 1 up to approximately 150 days after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 513 in people with Cardiometabolic Disease, run by Amgen at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAE) (time frame: Day 1 up to approximately 150 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.