Overweight or Obesity
Conditions
Keywords
AMG 133, Overweight, Obesity, MariTide
Brief 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
DRUGAMG 133
AMG 133 will be administered SC.
DRUGPlacebo
Placebo will be administered SC.
DRUGAcetaminophen
Acetaminophen will be administered orally.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) for Acetaminophen | Days 1, 3, 8, 17, 31, 59, 64, and 86 |
| AUC from Time Zero to Infinity (AUCinf) for Acetaminophen | Days 1, 3, 8, 17, 31, 59, 64, and 86 |
| Maximum Observed Plasma Concentration (Cmax) for Acetaminophen | Days 1, 3, 8, 17, 31, 59, 64, and 86 |
| AUC from Time Zero to 5 Hours (AUC5hr) for Acetaminophen | Days 1, 3, 8, 17, 31, 59, 64, and 86 |
| Time to Cmax (Tmax) for Acetaminophen | Days 1, 3, 8, 17, 31, 59, 64, and 86 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience Serious Adverse Events (SAEs) | Screening (Day -28) to Day 128 | — |
| Change from Baseline in Food Intake and Appetite | 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 | Day 2 up to Day 128 | — |
| Cmax for AMG 133 | 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 | 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 | 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) | Day 1 to Day 128 | — |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed