ObesityPhase 1NCT07908316
Comparing the Extent to Which Maridebart Cafraglutide is Made Available in the Body of Participants Living With Overweight or Obesity After Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA)
A Phase 1 study testing Maridebart cafraglutide in people with Obesity and Overweight, run by Amgen at 9 sites in United States.
Trial summary
The primary purpose of the study is to assess the pharmacokinetics of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Maridebart cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 9 sitesUnited States
- Study dates
- 13 Nov 2026to 25 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age.
- Body Mass Index (BMI) ≥ 25 at screening.
- BMI ≥ 23 for Asian participants at screening.
- Stable body weight (approximately 5% or less gain or loss) during the 4-week run-in period, unless the study doctor determines otherwise.
- Stable dose of weekly GLP-1RA.
- Stable gastrointestinal (GI) tolerability.
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- Contraception for females.
- Stable for 3 months if obstructive sleep apnea (OSA), hypertension, hyperlipidemia, and/or hypothyroidism.
- Willingness to follow trial procedures for the duration of the trial.
Who cannot join
- Type 1/Type 2 diabetes mellitus (DM).
- Obesity induced by other endocrine disorder (ex: Cushing's syndrome).
- History of malignancy in the last 5 tears except for nonmelanoma skin cancers, cervical, or breast ductal carcinoma in situ.
- Acute \& chronic pancreatitis within 1 year.
- Uncontrolled thyroid disease.
- Gastroparesis or gastric outlet obstruction.
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- Surgery for obesity in the last 6 months.
- Heart attack within 3 months.
- History of ischemic optic neuropathy.
- Positive HIV or certain positive Hepatitis B or hepatitis C.
- Current use of compounded weekly GLP-1RA.
- Previous participation in Maridebart cafraglutide trial.
- Alcohol or drug abuse.
- Pregnancy, breastfeeding, or planning to breastfeed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968
- Recruiting
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012-3437
- Recruiting
Alliance for Multispecialty Research - Knoxville
Knoxville, Tennessee, 37920-1534
- Recruiting
The Alliance for Multispecialty Research - Lexington
Lexington, Kentucky, 40509
- Recruiting
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
- Recruiting
K2 Medical Research Orlando
Maitland, Florida, 32751-7240
- Recruiting
Catalina Research Institute LLC (CRI) - Montclair
Montclair, California, 91763
- Recruiting
Arizona Research Center
Phoenix, Arizona, 85053
About this study
Official title: A Phase 1, Randomized, Double-blind, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Maridebart Cafraglutide After Switching From Glucagon-like Peptide-1 Receptor Agonists in Participants Living With Overweight or Obesity
The primary purpose of the study is to assess the pharmacokinetics of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity.
- Conditions
- Obesity, Overweight
- Being tested
- Maridebart cafraglutide
- Medical subject headings
- Obesity, Overweight
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, MariTide
Administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Group 1: Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide dosing schedule 1 during treatment period Receives: Drug: Maridebart cafraglutide |
| Cohort A Group 2: Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide dosing schedule 2 during treatment period. Receives: Drug: Maridebart cafraglutide |
| Cohort B Group 3: Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide dosing schedule 1 during treatment period Receives: Drug: Maridebart cafraglutide |
| Cohort B Group 4: Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide dosing schedule 2 during treatment period. Receives: Drug: Maridebart cafraglutide |
| Cohort C Group 5: Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide dosing schedule 1 during treatment period Receives: Drug: Maridebart cafraglutide |
| Cohort C Group 6: Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide dosing schedule 2 during treatment period 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 Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide
Measured: Up To 115 days
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Measured: Up To 115 days
Secondary outcomes (2)
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: TEAEs: From baseline (Day 1) up to end of trial (approximately 16 weeks). SAEs: From screening (Day -56) up to end of trial (approximately 24 weeks).
Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
Measured: Up To 115 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start13 Nov 2026 (estimated)
- Primary completion20 Dec 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
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
- NCT07908316
- Sponsor's protocol ID
- 20250233
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Maridebart Cafraglutide After Switching From Glucagon-like Peptide-1 Receptor Agonists in Participants Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07908316
- Acronym / sponsor ID
- 20250233
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 2 Nov 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 purpose of the study is to assess the pharmacokinetics of maridebart cafraglutode after switching from weekly GLP-1RA in participants living with overweight or obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A Group 1: Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide dosing schedule 1 during treatment period |
| Cohort A Group 2: Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide dosing schedule 2 during treatment period. |
| Cohort B Group 3: Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide dosing schedule 1 during treatment period |
| Cohort B Group 4: Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide dosing schedule 2 during treatment period. |
| Cohort C Group 5: Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide dosing schedule 1 during treatment period |
| Cohort C Group 6: Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide dosing schedule 2 during treatment period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 70 years of age.
- Body Mass Index (BMI) ≥ 25 at screening.
- BMI ≥ 23 for Asian participants at screening.
- Stable body weight (approximately 5% or less gain or loss) during the 4-week run-in period, unless the study doctor determines otherwise.
- Stable dose of weekly GLP-1RA.
Key exclusion criteria (14 listed)
- Type 1/Type 2 diabetes mellitus (DM).
- Obesity induced by other endocrine disorder (ex: Cushing's syndrome).
- History of malignancy in the last 5 tears except for nonmelanoma skin cancers, cervical, or breast ductal carcinoma in situ.
- Acute \& chronic pancreatitis within 1 year.
- Uncontrolled thyroid disease.
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 133, MariTideAdministered subcutaneously. | Drug | Cohort A Group 1: Maridebart Cafraglutide, Cohort A Group 2: Maridebart Cafraglutide, Cohort B Group 3: Maridebart Cafraglutide, Cohort B Group 4: Maridebart Cafraglutide, Cohort C Group 5: Maridebart Cafraglutide, Cohort C Group 6: Maridebart Cafraglutide |
Primary outcome
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide
Time frame: Up To 115 days
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time frame: Up To 115 days
2 secondary outcomes
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: TEAEs: From baseline (Day 1) up to end of trial (approximately 16 weeks). SAEs: From screening (Day -56) up to end of trial (approximately 24 weeks).
Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
Time frame: Up To 115 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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.
MD study director
Amgen
9 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 Obesity and Overweight, run by Amgen at 9 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau) of Maridebart Cafraglutide (time frame: Up To 115 days). The study lists 2 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 2 Nov 2026.