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

NCT07429045 | Completed Phase 1 FDA Drug

• 1 other identifier: 20230149
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

Obesity; AMG 133; Maridebart cafraglutide; MariTide

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Concentration (Cmax) of AMG 133

  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

  Up to Day 120

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

  Up to Day 120

Secondary Outcomes (3)

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

  Day 1 to Day 120

• Number of Participants who Experienced Serious AEs (SAEs)

  Screening to Day 120 (up to 148 days)

• Number of Participants with Positive Anti-AMG 133 Antibody Formation

  Up to Day 120

Study Arms (5)

Group 1: Normal renal function

EXPERIMENTAL

Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection.

Drug: AMG 133

Group 2: Mild renal impairment

EXPERIMENTAL

Participants with an eGFR of 60 to \< 90 mL/min will receive a single dose of AMG 133 as a SC injection.

Drug: AMG 133

Group 3: Moderate renal impairment

EXPERIMENTAL

Participants with an eGFR of 30 to \< 60 mL/min will receive a single dose of AMG 133 as a SC injection.

Drug: AMG 133

Group 4: Severe renal impairment and kidney failure not receiving hemodialysis

EXPERIMENTAL

Participants with an eGFR of \< 30 mL/min will receive a single dose of AMG 133 as a SC injection.

Drug: AMG 133

Group 5: Kidney failure receiving hemodialysis

EXPERIMENTAL

Participants with an eGFR of \< 15 mL/min will receive a single dose of AMG 133 as a SC injection.

Drug: AMG 133

Interventions

AMG 133 DRUG

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

Also known as: Maridebart cafraglutide

Group 1: Normal renal function; Group 2: Mild renal impairment; Group 3: Moderate renal impairment; Group 4: Severe renal impairment and kidney failure not receiving hemodialysis; Group 5: Kidney failure receiving hemodialysis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants in Groups 1 to 5
• Male or female, of any race, between 18 and 75 years of age, inclusive.
• a. Females must not be pregnant or lactating.
• Body mass index \> 22.0 kg/m2.
• Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable.
• Participants with Normal Renal Function
• 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
• Participants with renal impairment may have medical findings consistent with their renal dysfunction.

You may not qualify if:

• All Participants in Groups 1 to 5
• 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.
• History or evidence of endocrine disorder.
• 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.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients or to related/similar compounds.
• Active liver disease or hepatic dysfunction.
• Clinically significant hyperkalemia.
• Current use or prior use of any GLP-1R agonist, or GIPR agonist or antagonist within the past 3 months prior to check-in.
• Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives prior to AMG 133 dosing.
• 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)
• History of active diabetes or evidence based on hemoglobin A1C of \> 6.5% (\> 48 mmol/mol).
• Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
• A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile.

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

AdvancedPharma CR LLC

Miami, Florida, 33147-4040, United States

Location

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

Omega Research Group, LLC - Orlando

Orlando, Florida, 32806-1133, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 11, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: February 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (5)