Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Kidney function may affect how obesity drug works

NCT ID NCT07429045

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

44 people

The number who actually took part.

Started

Mar 2025

Finished

Nov 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 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Overweight and obesity are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • AdvancedPharma CR LLC

    Miami, Florida, 33147-4040, United States

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida, 33016, United States

  • Omega Research Group, LLC - Orlando

    Orlando, Florida, 32806-1133, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809-3017, United States

More trials for these conditions

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