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

NCT ID: NCT07310563

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-05-09

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Keywords

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Antiemetic Drug-drug Interaction AMG 133 Ondansetron Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low Dose AMG 133 without Ondansetron

Participants will receive a single subcutaneous (SC) low dose of 70 mg AMG 133.

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

AMG 133 will be administered SC.

High Dose AMG 133 without Ondansetron

Participants will receive a single SC high dose of 350 mg AMG 133.

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

AMG 133 will be administered SC.

Low Dose AMG 133 with Ondansetron

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.

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

AMG 133 will be administered SC.

Ondansetron

Intervention Type DRUG

Ondansetron will be administered via ODT.

High Dose AMG 133 with Ondansetron

Participants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours.

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

AMG 133 will be administered SC.

Ondansetron

Intervention Type DRUG

Ondansetron will be administered via ODT.

Interventions

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AMG 133

AMG 133 will be administered SC.

Intervention Type DRUG

Ondansetron

Ondansetron will be administered via ODT.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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CenExel Collaborative Neuroscience Research, LLC Los Alamitos

Los Alamitos, California, United States

Site Status

Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20210281

Identifier Type: -

Identifier Source: org_study_id