Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07429032
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07429032
Study Brief:
Protocol Section:
NCT07429032