OverweightPhase 1NCT07226778
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations
A Phase 1 study testing Maridebart Cafraglutide in people with Overweight and Obesity, run by Amgen at 4 sites in United States.
Trial summary
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Maridebart Cafraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Oct 2025to 28 May 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, of any race, between 18 and 60 years of age, inclusive.
- Females must not be pregnant or lactating.
- Body mass index between ≥25.0 and <40.0 kg/m^2.
Who cannot join
- History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
- History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of >500 mg/dL at screening.
- Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
Show all 15Show fewer
- History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina.
- History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
- History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients.
- Estimated glomerular filtration rate ≤60 mL/min/1.73 m^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- 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 prior to check-in.
- Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate.
- Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in.
- Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials
Anaheim, California, 92801-2658
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4989
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
About this study
Official title: A Phase 1, Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
- Conditions
- Overweight, Obesity
- Being tested
- Maridebart Cafraglutide
- Keywords
- Overweight, Obesity, Maridebart Cafraglutide, AMG 133, 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.
Maridebart CafraglutideDrug
Also called AMG 133
Maridebart cafraglutide will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Maridebart Cafraglutide SC Presentation 1 | Experimental | Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1. Receives: Drug: Maridebart Cafraglutide |
| Maridebart Cafraglutide SC Presentation 2 | Active comparator | Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2. Receives: Drug: Maridebart Cafraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide
Measured: Up to Day 120
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Measured: Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Measured: Up to Day 120
Secondary outcomes (3)
Number of Participants with Treatment-emergent Adverse Events
Measured: Up to Day 120
Number of Participants with Serious Adverse Events
Measured: Up to Day 120
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Measured: Up to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start10 Oct 2025
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 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
- NCT07226778
- Sponsor's protocol ID
- 20230259
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2025
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07226778
- Acronym / sponsor ID
- 20230259
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Maridebart Cafraglutide, AMG 133, MariTide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 10 Nov 2025 (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 main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maridebart Cafraglutide SC Presentation 1 | Experimental | Drug: Maridebart CafraglutideParticipants will receive a single dose of maridebart cafraglutide administered using SC presentation 1. |
| Maridebart Cafraglutide SC Presentation 2 | Active comparator | Drug: Maridebart CafraglutideParticipants will receive a single dose of maridebart cafraglutide administered using SC presentation 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female, of any race, between 18 and 60 years of age, inclusive.
- Body mass index between ≥25.0 and <40.0 kg/m^2.
Key exclusion criteria (15 listed)
- History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
- History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of >500 mg/dL at screening.
- Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
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 |
|---|---|---|
| Maridebart CafraglutideAlso: AMG 133Maridebart cafraglutide will be administered SC. | Drug | Maridebart Cafraglutide SC Presentation 1, Maridebart Cafraglutide SC Presentation 2 |
Primary outcome
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide
Time frame: Up to Day 120
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Time frame: Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time frame: Up to Day 120
3 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to Day 120
Number of Participants with Serious Adverse Events
Time frame: Up to Day 120
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame: Up to Day 120
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 17 Jun 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maridebart Cafraglutide in people with Overweight and Obesity, run by Amgen at 4 sites 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 15 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide (time frame: Up to Day 120). The study lists 3 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 17 Jun 2026.