OverweightPhase 1NCT07310563
A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity
A Phase 1 study testing AMG 133 and Ondansetron in people with Overweight and Obesity, run by Amgen at 1 site in United States.
Trial summary
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- AMG 133 and Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 9 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants, between 18 and 65 years of age.
- Body mass index > 25 kg/m^2.
Who cannot join
- History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
- History of or active diabetes or hemoglobin A1C > 6.5%.
- History or evidence of endocrine disorder.
- History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (> 2 x upper limit of normal [ULN]), or fasting serum triglyceride level of > 500 mg/dL.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- Uncontrolled thyroid disease.
Show all 15Show fewer
- History or current signs or symptoms of cardiovascular disease.
- A QT interval corrected for heart rate based on the Fridericia's method (QTcF) interval > 450 msec in male participants or > 470 msec in female participants or history/evidence of long QT syndrome.
- History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients.
- Any contraindication to ondansetron ODT according to the applicable labelling.
- Alanine aminotransferase or aspartate aminotransferase > 2 x the ULN.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- Current use or prior use of any glucagon-like peptide 1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months.
- Participant has received a dose of an investigational medicinal product (IMP) within the past 30 days or 5 half-lives.
- Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the IMP.
Trial locations and contacts
1 site in 1 country.
United States1 site
CenExel Collaborative Neuroscience Research, LLC Los Alamitos
Los Alamitos, California, 90720
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-group, Drug-drug Interaction Study to Evaluate the Effect of Antiemetic Medication on the Pharmacokinetics of AMG 133 in Participants Living With Overweight or Obesity
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity.
- Conditions
- Overweight, Obesity
- Being tested
- AMG 133, Ondansetron
- Keywords
- Antiemetic, Drug-drug Interaction, AMG 133, Ondansetron, Overweight, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 133Drug
AMG 133 will be administered SC.
OndansetronDrug
Ondansetron will be administered via ODT.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose AMG 133 without Ondansetron | Experimental | Participants will receive a single subcutaneous (SC) low dose of 70 mg AMG 133. Receives: Drug: AMG 133 |
| High Dose AMG 133 without Ondansetron | Experimental | Participants will receive a single SC high dose of 350 mg AMG 133. Receives: Drug: AMG 133 |
| Low Dose AMG 133 with Ondansetron | Experimental | Participants will receive a single SC low dose of 70 mg AMG 133 and ondansetron 8 mg orally disintegrating tablet (ODT) every 8 hours for 72 hours. Receives: Drug: AMG 133; Drug: Ondansetron |
| High Dose AMG 133 with Ondansetron | Experimental | Participants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours. Receives: Drug: AMG 133; Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Measured: Up to Day 120
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
Measured: Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Measured: Up to Day 120
Secondary outcomes (3)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Day 120
Number of Participants with Serious AEs (SAEs)
Measured: Up to Day 120
Number of Participants with Anti-AMG 133 Antibodies
Measured: Up to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start10 Dec 2024
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT07310563
- Sponsor's protocol ID
- 20210281
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-group, Drug-drug Interaction Study to Evaluate the Effect of Antiemetic Medication on the Pharmacokinetics of AMG 133 in Participants Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07310563
- Acronym / sponsor ID
- 20210281
- Conditions
- Overweight, Obesity
- Keywords
- Antiemetic, Drug-drug Interaction, AMG 133, Ondansetron, Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 30 Dec 2025 (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 trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose AMG 133 without Ondansetron | Experimental | Drug: AMG 133Participants will receive a single subcutaneous (SC) low dose of 70 mg AMG 133. |
| High Dose AMG 133 without Ondansetron | Experimental | Drug: AMG 133Participants will receive a single SC high dose of 350 mg AMG 133. |
| Low Dose AMG 133 with Ondansetron | Experimental | Drug: AMG 133, Drug: OndansetronParticipants will receive a single SC low dose of 70 mg AMG 133 and ondansetron 8 mg orally disintegrating tablet (ODT) every 8 hours for 72 hours. |
| High Dose AMG 133 with Ondansetron | Experimental | Drug: AMG 133, Drug: OndansetronParticipants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female participants, between 18 and 65 years of age.
- Body mass index > 25 kg/m^2.
Key exclusion criteria (15 listed)
- History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
- History of or active diabetes or hemoglobin A1C > 6.5%.
- History or evidence of endocrine disorder.
- History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (> 2 x upper limit of normal [ULN]), or fasting serum triglyceride level of > 500 mg/dL.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
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 133AMG 133 will be administered SC. | Drug | High Dose AMG 133 with Ondansetron, High Dose AMG 133 without Ondansetron, Low Dose AMG 133 with Ondansetron, Low Dose AMG 133 without Ondansetron |
| OndansetronOndansetron will be administered via ODT. | Drug | High Dose AMG 133 with Ondansetron, Low Dose AMG 133 with Ondansetron |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Time frame: Up to Day 120
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
Time frame: Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Time frame: Up to Day 120
3 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 120
Number of Participants with Serious AEs (SAEs)
Time frame: Up to Day 120
Number of Participants with Anti-AMG 133 Antibodies
Time frame: Up to Day 120
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 13 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
1 site 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 133 and Ondansetron in people with Overweight and Obesity, run by Amgen at 1 site 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 15 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 13 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 1 site 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?
Maximum Observed Plasma Concentration (Cmax) of AMG 133 (time frame: Up to Day 120). The study lists 3 primary outcomes in all. 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 13 Oct 2026.