Overweight and ObesityPhase 1NCT07429045
A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body
A Phase 1 study testing AMG 133 in people with Overweight and Obesity, run by Amgen at 5 sites in United States.
Trial summary
The primary objective of this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- AMG 133
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Mar 2025to 21 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants in Groups 1 to 5
- Male or female, of any race, between 18 and 75 years of age, inclusive.
- Females must not be pregnant or lactating.
- Body mass index > 22.0 kg/m2.
- Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable.
- Participants with Normal Renal Function
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- In good health as determined by no clinically significant findings from medical history, physical examination, vital signs measurements, 12-lead ECGs, and clinical laboratory evaluations.
- Participants with Renal Impairment
- Participants with renal impairment may have medical findings consistent with their renal dysfunction.
Who cannot join
- All Participants in Groups 1 to 5
- 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 or evidence of endocrine disorder.
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (> 2 x ULN) at screening, or fasting serum triglyceride level of > 500 mg/dL at screening.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients or to related/similar compounds.
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- Active liver disease or hepatic dysfunction.
- Clinically significant hyperkalemia.
- Current use or prior use of any GLP-1R agonist, or GIPR agonist or antagonist within the past 3 months prior to check-in.
- Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives prior to AMG 133 dosing.
- Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product.
- Participants with Normal Renal Function (Group 1)
- History of active diabetes or evidence based on hemoglobin A1C of > 6.5% (> 48 mmol/mol).
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile.
- Participants with Renal Impairment (Groups 2 to 5)
- Participants who have a current, functioning organ transplant and/or are on immunosuppressants.
- Participants on the national transplant list who anticipate receiving an organ transplant within 6 months of check-in.
- History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives before check-in.
- History of poorly controlled diabetes or evidence based on hemoglobin A1C of > 11% (> 97 mmol/mol).
- Active malignancy of any type.
- A change in renal disease status within 30 days of screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Orange County Research Center
Lake Forest, California, 92630
AdvancedPharma CR LLC
Miami, Florida, 33147-4040
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
Omega Research Group, LLC - Orlando
Orlando, Florida, 32806-1133
Orlando Clinical Research Center
Orlando, Florida, 32809-3017
About this study
Official title: A Phase 1, Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AMG 133 in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment
The primary objective of this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal function.
- Conditions
- Overweight and Obesity
- Being tested
- AMG 133
- Keywords
- Obesity, AMG 133, Maridebart cafraglutide, 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
Participants will receive one dose of AMG 133 as a SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Normal renal function | Experimental | Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection. Receives: Drug: AMG 133 |
| Group 2: Mild renal impairment | Experimental | Participants with an eGFR of 60 to < 90 mL/min will receive a single dose of AMG 133 as a SC injection. Receives: Drug: AMG 133 |
| Group 3: Moderate renal impairment | Experimental | Participants with an eGFR of 30 to < 60 mL/min will receive a single dose of AMG 133 as a SC injection. Receives: Drug: AMG 133 |
| Group 4: Severe renal impairment and kidney failure not receiving hemodialysis | Experimental | Participants with an eGFR of < 30 mL/min will receive a single dose of AMG 133 as a SC injection. Receives: Drug: AMG 133 |
| Group 5: Kidney failure receiving hemodialysis | Experimental | Participants with an eGFR of < 15 mL/min will receive a single dose of AMG 133 as a SC injection. Receives: Drug: AMG 133 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of AMG 133
Measured: Up to Day 120
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
Measured: Up to Day 120
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
Measured: Up to Day 120
Secondary outcomes (3)
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 to Day 120
Number of Participants who Experienced Serious AEs (SAEs)
Measured: Screening to Day 120 (up to 148 days)
Number of Participants with Positive Anti-AMG 133 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 posted24 Feb 2026
- Study start11 Mar 2025
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT07429045
- Sponsor's protocol ID
- 20230149
- Status last verified
- Dec 2025
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- 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, Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AMG 133 in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT07429045
- Acronym / sponsor ID
- 20230149
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, AMG 133, Maridebart cafraglutide, MariTide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 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 this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Normal renal function | Experimental | Drug: AMG 133Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 2: Mild renal impairment | Experimental | Drug: AMG 133Participants with an eGFR of 60 to < 90 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 3: Moderate renal impairment | Experimental | Drug: AMG 133Participants with an eGFR of 30 to < 60 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 4: Severe renal impairment and kidney failure not receiving hemodialysis | Experimental | Drug: AMG 133Participants with an eGFR of < 30 mL/min will receive a single dose of AMG 133 as a SC injection. |
| Group 5: Kidney failure receiving hemodialysis | Experimental | Drug: AMG 133Participants with an eGFR of < 15 mL/min will receive a single dose of AMG 133 as a SC injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All Participants in Groups 1 to 5
- Male or female, of any race, between 18 and 75 years of age, inclusive.
- Body mass index > 22.0 kg/m2.
- Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable.
- Participants with Normal Renal Function
Key exclusion criteria (23 listed)
- All Participants in Groups 1 to 5
- 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 or evidence of endocrine disorder.
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (> 2 x ULN) at screening, or fasting serum triglyceride level of > 500 mg/dL at screening.
- 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 cafraglutideParticipants will receive one dose of AMG 133 as a SC injection. | Drug | Group 1: Normal renal function, Group 2: Mild renal impairment, Group 3: Moderate renal impairment, Group 4: Severe renal impairment and kidney failure not receiving hemodialysis, Group 5: Kidney failure receiving hemodialysis |
Primary outcome
Maximum Observed Concentration (Cmax) of AMG 133
Time frame: Up to Day 120
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
Time frame: Up to Day 120
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
Time frame: Up to Day 120
3 secondary outcomes
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 120
Number of Participants who Experienced Serious AEs (SAEs)
Time frame: Screening to Day 120 (up to 148 days)
Number of Participants with Positive Anti-AMG 133 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 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
5 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 AMG 133 in people with Overweight and Obesity, run by Amgen at 5 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 23 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 5 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?
Maximum Observed Concentration (Cmax) of AMG 133 (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 24 Feb 2026.