Does Anti-Nausea drug affect new Weight-Loss treatment? study answers
NCT ID NCT07310563
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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59 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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May 2025
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CenExel Collaborative Neuroscience Research, LLC Los Alamitos
Los Alamitos, California, 90720, United States
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