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Does Anti-Nausea drug affect new Weight-Loss treatment? study answers

NCT ID NCT07310563

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether taking an anti-nausea drug (ondansetron) along with AMG 133 changes how the body processes AMG 133. Fifty-nine adults with overweight or obesity participated. The goal was to measure drug levels and check for side effects, not to treat the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

59 people

The number who actually took part.

Started

Dec 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CenExel Collaborative Neuroscience Research, LLC Los Alamitos

    Los Alamitos, California, 90720, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.