NCT07310563CompletedPhase 1
A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 16 Dec 2025
- Start date
- 10 Dec 2024
- Primary completion date
- 9 May 2025
- Lead sponsor
- Amgen
- Diseases
- Obesity
- NCT number
- NCT07310563
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 59
- From 10 Dec 2024 to the primary completion date, 9 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- 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- Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the IMP.
Other illness
- 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 or evidence of endocrine disorder.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- Uncontrolled thyroid disease.
- History or current signs or symptoms of cardiovascular disease.
- History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients.
Lab values
- History of or active diabetes or hemoglobin A1C \> 6.5%.
- 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.
- 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.
- Alanine aminotransferase or aspartate aminotransferase \> 2 x the ULN.
- 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.
Other
- Any contraindication to ondansetron ODT according to the applicable labelling.
Who the study is looking for
- Male or female participants, between 18 and 65 years of age.
- Body mass index \> 25 kg/m\^2.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel Collaborative Neuroscience Research, LLC Los Alamitos Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.