Kidney function may affect how obesity drug works
NCT ID NCT07429045
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a single dose of the drug AMG 133 is processed by the body in people with normal kidney function compared to those with various levels of kidney problems. A total of 44 adults aged 18 to 75 who are overweight or obese took part. The goal was to understand safety and drug levels, not to treat obesity directly.
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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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44 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Nov 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 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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 All Participants in Groups 1 to 5 1. Male or female, of any race, between 18 and 75 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index \> 22.0 kg/m2. 3. Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable. Participants with Normal Renal Function 4. In good health as determined by no clinically significant findings from medical history, physical examination, vital signs measurements, 12-lead ECGs, and clinical laboratory evaluations. Participants with Renal Impairment 5. Participants with renal impairment may have medical findings consistent with their renal dysfunction. Exclusion Criteria All Participants in Groups 1 to 5 1. History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. 2. History or evidence of endocrine disorder. 3. History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (\> 2 x ULN) at screening, or fasting serum triglyceride level of \> 500 mg/dL at screening. 4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 5. History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients or to related/similar compounds. 6. Active liver disease or hepatic dysfunction. 7. Clinically significant hyperkalemia. 8. Current use or prior use of any GLP-1R agonist, or GIPR agonist or antagonist within the past 3 months prior to check-in. 9. Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives prior to AMG 133 dosing. 10. Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product. Participants with Normal Renal Function (Group 1) 11. History of active diabetes or evidence based on hemoglobin A1C of \> 6.5% (\> 48 mmol/mol). 12. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 13. A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile. Participants with Renal Impairment (Groups 2 to 5) 14. Participants who have a current, functioning organ transplant and/or are on immunosuppressants. 15. Participants on the national transplant list who anticipate receiving an organ transplant within 6 months of check-in. 16. History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study. 17. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives before check-in. 18. History of poorly controlled diabetes or evidence based on hemoglobin A1C of \> 11% (\> 97 mmol/mol). 19. Active malignancy of any type. 20. A change in renal disease status within 30 days of screening.
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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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AdvancedPharma CR LLC
Miami, Florida, 33147-4040, United States
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Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016, United States
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Omega Research Group, LLC - Orlando
Orlando, Florida, 32806-1133, United States
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Orange County Research Center
Lake Forest, California, 92630, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809-3017, United States
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