NCT07429032CompletedPhase 1
The Effect of AMG 133 on Gastric Emptying
A Phase 1, Randomized, Double Blind, Multiple Dose, Placebo-controlled, Parallel Group Study to Evaluate the Impact of AMG 133 on Gastric Emptying in Participants Living With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 18 Feb 2026
- Start date
- 17 Apr 2025
- Primary completion date
- 26 Nov 2025
- Lead sponsor
- Amgen
- Diseases
- Obesity
- NCT number
- NCT07429032
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 57
- From 17 Apr 2025 to the primary completion date, 26 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to swallow oral medication.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives.
- 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- Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the IMP.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.
Other illness
- 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.
- 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.
Lab values
- History of or active diabetes or Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol).
- 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.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x the upper limit of normal.
- 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.
Other
- Any contraindication to acetaminophen according to the applicable labelling.
Who the study is looking for
- Male or female participants between 18 and 65 years of age.
- Females must not be pregnant or lactating.
- Body mass index between ≥ 27 to \< 40 kg/m\^2.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fortrea Clinical Research Unit - Daytona Beach Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.