The Effect of AMG 133 on Gastric Emptying

Completed · Phase 1 · Has a placebo group

Conditions studied: Overweight or Obesity

In brief

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.

Key facts

Study ID

NCT07429032

Run by

Amgen

People needed

57

Starts

2025-04-17

Expected to finish

2025-11-26

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Fortrea Clinical Research Unit - Daytona Beach — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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