Current partner codePEPTIDESDE
NCT07310563·Phase 1·INTERVENTIONAL

A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity

Status

Completed

Phase

Phase 1

Enrollment

59

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

AMG 133

AMG 133 will be administered SC.

DRUG

Ondansetron

Ondansetron will be administered via ODT.

Timeline

From registration to results.

  1. First posted

    Dec 30, 2025

  2. Study start

    Dec 10, 2024

  3. Primary completion

    May 9, 2025

  4. Study completion

    May 9, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Dec 30, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

CenExel Collaborative Neuroscience Research, LLC Los Alamitos

Los Alamitos, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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