DRUG
AMG 133
AMG 133 will be administered SC.
Status
Completed
Phase
Phase 1
Enrollment
57
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
AMG 133 will be administered SC.
DRUG
Placebo will be administered SC.
DRUG
Acetaminophen will be administered orally.
Timeline
First posted
Feb 24, 2026
Study start
Apr 17, 2025
Primary completion
Nov 26, 2025
Study completion
Nov 26, 2025
Results posted
Not reported
Registry updated
Feb 24, 2026
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
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
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
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
No PMID-linked publications were present in this registry snapshot.
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