The Effect of AMG 133 on Gastric Emptying

NCT07429032 | Completed Phase 1 FDA Drug

• 1 other identifier: 20230012
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the trial is to evaluate the effect of AMG 133 versus placebo on acetaminophen pharmacokinetics (PK), a marker for gastric emptying, in participants living with overweight or obesity.

Conditions

Overweight or Obesity

Keywords

AMG 133; Overweight; Obesity; MariTide

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax) for Acetaminophen

  Days 1, 3, 8, 17, 31, 59, 64, and 86

• Time to Cmax (Tmax) for Acetaminophen

  Days 1, 3, 8, 17, 31, 59, 64, and 86

• Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) for Acetaminophen

  Days 1, 3, 8, 17, 31, 59, 64, and 86

• AUC from Time Zero to Infinity (AUCinf) for Acetaminophen

  Days 1, 3, 8, 17, 31, 59, 64, and 86

• AUC from Time Zero to 5 Hours (AUC5hr) for Acetaminophen

  Days 1, 3, 8, 17, 31, 59, 64, and 86

Secondary Outcomes (7)

• Cmax for AMG 133

  Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128

• AUClast for AMG 133

  Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128

• AUCinf for AMG 133

  Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128

• Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)

  Day 1 to Day 128

• Number of Participants Who Experience Serious Adverse Events (SAEs)

  Screening (Day -28) to Day 128

Study Arms (2)

AMG 133

EXPERIMENTAL

Participants will receive AMG 133 subcutaneously (SC) and acetaminophen orally.

Drug: AMG 133; Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC and acetaminophen orally.

Drug: Placebo; Drug: Acetaminophen

Interventions

AMG 133 DRUG

AMG 133 will be administered SC.

Also known as: Maridebart cafraglutide

AMG 133

Placebo DRUG

Placebo will be administered SC.

Placebo

Acetaminophen DRUG

Acetaminophen will be administered orally.

AMG 133; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants between 18 and 65 years of age.
• a. Females must not be pregnant or lactating.
• Body mass index between ≥ 27 to \< 40 kg/m\^2.

You may not qualify if:

• 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 of or active diabetes or Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol).
• History or evidence of endocrine disorder.
• History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (\> 2 x the upper limit of normal \[ULN\]), or fasting serum triglyceride level of \> 500 mg/dL.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• Uncontrolled thyroid disease.
• History of or current signs of gastroparesis.
• History or current signs or symptoms of cardiovascular disease.
• History suggestive of esophageal, gastric, or duodenal ulceration or bowel disease; or a history of gastrointestinal surgery other than uncomplicated appendectomy or hernia repair.
• History of gastrointestinal tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, gastric/jejunal tube feeds, or uncontrolled inflammatory gastrointestinal disease.
• History of hypersensitivity, intolerance, or allergy to AMG 133 or related/similar compounds or acetaminophen or their ingredients.
• Any contraindication to acetaminophen according to the applicable labelling.
• Inability to swallow oral medication.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x the upper limit of normal.
• Use of any over-the-counter or prescription medications within 30 days or 5 half-lives.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: April 17, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 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 (1)