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Completed

NCT Number: NCT07310563

A Trial to Evaluate Interactions Between Antiemetic Medication and 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel Collaborative Neuroscience Research, LLC Los Alamitos

Los Alamitos, California, 90720, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants, between 18 and 65 years of age.
  • Body mass index > 25 kg/m^2.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

AMG 133

Drug

AMG 133 will be administered SC.

ondansetron

Drug

Ondansetron will be administered via ODT.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of AMG 133

    Time frame: Up to Day 120

  2. 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

  3. AUC from Time Zero to Infinity (AUCinf) of AMG 133

    Time frame: Up to Day 120

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Day 120

  2. Number of Participants with Serious AEs (SAEs)

    Time frame: Up to Day 120

  3. Number of Participants with Anti-AMG 133 Antibodies

    Time frame: Up to Day 120

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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