Current partner codePEPTIDESDE
NCT07429045·Phase 1·INTERVENTIONAL

A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body

Status

Completed

Phase

Phase 1

Enrollment

44

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The primary objective of this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal function.

Interventions

Treatment arms and agents.

DRUG

AMG 133

Participants will receive one dose of AMG 133 as a SC injection.

Timeline

From registration to results.

  1. First posted

    Feb 24, 2026

  2. Study start

    Mar 11, 2025

  3. Primary completion

    Nov 21, 2025

  4. Study completion

    Nov 21, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Feb 24, 2026

Outcomes

What the study measures.

Primary outcomes

Maximum Observed Concentration (Cmax) of AMG 133

Time frame · Up to Day 120

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133

Time frame · Up to Day 120

AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133

Time frame · Up to Day 120

Secondary outcomes

Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

Time frame · Day 1 to Day 120

Number of Participants who Experienced Serious AEs (SAEs)

Time frame · Screening to Day 120 (up to 148 days)

Number of Participants with Positive Anti-AMG 133 Antibody Formation

Time frame · Up to Day 120

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

5 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Orange County Research Center

Lake Forest, California, United States

AdvancedPharma CR LLC

Miami, Florida, United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

Omega Research Group, LLC - Orlando

Orlando, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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