GLP-1 Peptide Atlas, by Delfa

CompletedPhase 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

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-40

Primary endpoints

•Cmax for Acetaminophen•Cmax (Tmax) for Acetaminophen•AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07429032

Org study ID20230012

Timeline

Milestones

Study start2025-04-17actual

Primary completion2025-11-26actual

Study completion2025-11-26actual

Study first posted2026-02-24actual

Last update posted2026-02-24actual

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes