Overweight or ObesityPhase 1NCT07429032
The Effect of AMG 133 on Gastric Emptying
A Phase 1 study testing AMG 133 and Acetaminophen in people with Overweight or Obesity, run by Amgen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- AMG 133 and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 26 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117
About this study
Official title: 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
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.
- Conditions
- Overweight or Obesity
- Being tested
- AMG 133, Placebo, Acetaminophen
- Keywords
- AMG 133, Overweight, Obesity, MariTide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 133Drug
Also called Maridebart cafraglutide
AMG 133 will be administered SC.
PlaceboDrug
Placebo will be administered SC.
AcetaminophenDrug
Acetaminophen will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| AMG 133 | Experimental | Participants will receive AMG 133 subcutaneously (SC) and acetaminophen orally. Receives: Drug: AMG 133; Drug: Acetaminophen |
| Placebo | Placebo comparator | Participants will receive placebo SC and acetaminophen orally. Receives: Drug: Placebo; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) for Acetaminophen
Measured: Days 1, 3, 8, 17, 31, 59, 64, and 86
Time to Cmax (Tmax) for Acetaminophen
Measured: 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
Measured: Days 1, 3, 8, 17, 31, 59, 64, and 86
AUC from Time Zero to Infinity (AUCinf) for Acetaminophen
Measured: Days 1, 3, 8, 17, 31, 59, 64, and 86
AUC from Time Zero to 5 Hours (AUC5hr) for Acetaminophen
Measured: Days 1, 3, 8, 17, 31, 59, 64, and 86
Secondary outcomes (7)
Cmax for AMG 133
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 1 to Day 128
Number of Participants Who Experience Serious Adverse Events (SAEs)
Measured: Screening (Day -28) to Day 128
Change from Baseline in Food Intake and Appetite
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.
Measured: Baseline to Day 64
Number of Participants Who Develop Anti-AMG 133 Antibodies
Measured: Day 2 up to Day 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start17 Apr 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429032
- Sponsor's protocol ID
- 20230012
- Status last verified
- Dec 2025
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07429032
- Acronym / sponsor ID
- 20230012
- Conditions
- Overweight or Obesity
- Keywords
- AMG 133, Overweight, Obesity, MariTide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 133 | Experimental | Drug: AMG 133, Drug: AcetaminophenParticipants will receive AMG 133 subcutaneously (SC) and acetaminophen orally. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: AcetaminophenParticipants will receive placebo SC and acetaminophen orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants between 18 and 65 years of age.
- Body mass index between ≥ 27 to < 40 kg/m^2.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 133Also: Maridebart cafraglutideAMG 133 will be administered SC. | Drug | AMG 133 |
| PlaceboPlacebo will be administered SC. | Drug | Placebo |
| AcetaminophenAcetaminophen will be administered orally. | Drug | AMG 133, Placebo |
Primary outcome
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
7 secondary outcomes
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
Number of Participants Who Develop Anti-AMG 133 Antibodies
Time frame: Day 2 up to Day 128
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 133 and Acetaminophen in people with Overweight or Obesity, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) for Acetaminophen (time frame: Days 1, 3, 8, 17, 31, 59, 64, and 86). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.