Current partner codePEPTIDESDE
NCT07429032·Phase 1·INTERVENTIONAL

The Effect of AMG 133 on Gastric Emptying

Status

Completed

Phase

Phase 1

Enrollment

57

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

AMG 133

AMG 133 will be administered SC.

DRUG

Placebo

Placebo will be administered SC.

DRUG

Acetaminophen

Acetaminophen will be administered orally.

Timeline

From registration to results.

  1. First posted

    Feb 24, 2026

  2. Study start

    Apr 17, 2025

  3. Primary completion

    Nov 26, 2025

  4. Study completion

    Nov 26, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Feb 24, 2026

Outcomes

What the study measures.

Primary outcomes

Maximum Observed Plasma Concentration (Cmax) for Acetaminophen

Time frame · Days 1, 3, 8, 17, 31, 59, 64, and 86

Time to Cmax (Tmax) for Acetaminophen

Time frame · 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

Time frame · Days 1, 3, 8, 17, 31, 59, 64, and 86

AUC from Time Zero to Infinity (AUCinf) for Acetaminophen

Time frame · Days 1, 3, 8, 17, 31, 59, 64, and 86

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

Time frame · Days 1, 3, 8, 17, 31, 59, 64, and 86

Secondary outcomes

Cmax for AMG 133

Time frame · 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

Time frame · 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

Time frame · 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)

Time frame · Day 1 to Day 128

Number of Participants Who Experience Serious Adverse Events (SAEs)

Time frame · Screening (Day -28) to Day 128

Change from Baseline in Food Intake and Appetite

Time frame · Baseline to Day 64

Change in Food intake during the ad libitum lunch and appetite visual analogue scale (VAS) scores in participants receiving AMG 133 and placebo will be evaluated.

Number of Participants Who Develop Anti-AMG 133 Antibodies

Time frame · Day 2 up to Day 128

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Current use or prior use of any glucagon-like peptide 1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months. * Current or prior use of all herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment. * Participant has received a dose of an investigational medicinal product (IMP) within the past 30 days or 5 half-lives. * Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the IMP. * Current use of acute or chronic medication known to affect gastric emptying.

Study locations

1 registered sites.

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

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, 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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