New weight loss drug candidate shows early promise in stomach study
NCT ID NCT07429032
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new drug called AMG 133 (Maridebart cafraglutide) in 57 adults with overweight or obesity. The goal was to see how the drug affects stomach emptying, using acetaminophen as a marker. Participants received either the drug or a placebo, and researchers measured how quickly the stomach emptied. The study is complete, but results are not yet public.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AMG 133 (Maridebart cafraglutide)
- What this could lead to
- If successful, this could help develop a new weight management drug that slows stomach emptying, potentially aiding weight loss.
- What could go wrong
- This is a very early Phase 1 trial with only 57 people, focused on stomach emptying rather than weight loss itself. The drug may not prove effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
57 people
The number who actually took part.
- Started
-
Apr 2025
- Finished
-
Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117, United States
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