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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
Lead sponsor
Asset
Maridebart cafraglutide / MariTide
Subcutaneous · GLP-1 agonist / GIP antagonist
Listed sites
1
Recruiting sites
—
Enrollment
59
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥25
Primary endpoints
•Cmax of AMG 133•AUC
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male or female participants, between 18 and 65 years of age.
2. Body mass index > 25 kg/m^2.
Exclusion criteria
1. 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.
2. History of or active diabetes or hemoglobin A1C > 6.5%.
3. History or evidence of endocrine disorder.
4. 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.
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
6. Uncontrolled thyroid disease.
7. History or current signs or symptoms of cardiovascular disease.
8. 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.
9. History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients.
10. Any contraindication to ondansetron ODT according to the applicable labelling.
11. Alanine aminotransferase or aspartate aminotransferase > 2 x the ULN.
12. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
13. 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.
14. Participant has received a dose of an investigational medicinal product (IMP) within the past 30 days or 5 half-lives.
15. Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the IMP.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
6 endpointsMaximum Observed Plasma Concentration (Cmax) of AMG 133
Time frame:Up to Day 120
Cmax
concentration, descriptive
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
AUC₀–∞
concentration, descriptive
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Time frame:Up to Day 120
AUC₀–∞
concentration, descriptive
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame:Up to Day 120
Treatment-emergent AEs (any)
event count, event
Number of Participants with Serious AEs (SAEs)
Time frame:Up to Day 120
Serious AEs (any)
event count, event
Number of Participants with Anti-AMG 133 Antibodies
Time frame:Up to Day 120
Immunogenicity (ADA)
threshold achievement, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.