OverweightPhase 1NCT06976372
A Study to Evaluate AMG 133 Administered Subcutaneously in Participants With Overweight or Obesity
A Phase 1 study testing AMG 133 in people with Overweight and Obesity, run by Amgen at 3 sites in United States.
Trial summary
The primary objective of this study is to assess the pharmacokinetics (PK) of AMG 133 after multiple subcutaneous (SC) administrations in participants with overweight or obesity using various dose regimens. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- AMG 133
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2024to 27 Dec 2024
- 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
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Male or female participants, between 18 and 65 years of age (inclusive) at the time of Screening.
- Except for obesity, no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee). Participants with obstructive sleep apnea, controlled hypertension, and/or controlled dyslipidemia on stable therapies will be permitted. Participants with other mild, well-controlled comorbidities may be permitted with approval of the Investigator (or designee) in consultation with the Medical Monitor as appropriate.
- Body mass index ≥ 27 kg/m^2 at the time of Screening.
- Have a stable body weight (< 5 kg self-reported change) within 3 months before Screening, as assessed by the Investigator (or designee) based on participant self-report. Have not modified diet or adopted any nutritional lifestyle modification for 3 months, as assessed by the Investigator (or designee) based on participant self-report.
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 gestational diabetes), or Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol), at Screening.
- History or evidence of endocrine disorder (such as 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 (> 2x the upper limit of normal) at Screening, or fasting serum triglyceride level of > 500 mg/dL at Screening. One repeat of abnormal values will be allowed.
- 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 25Show fewer
- Uncontrolled thyroid disease, defined as thyroid-stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L at Screening. Participants who receive treatment for hypothyroidism are permitted if their thyroid hormone replacement dose has been stable for 3 months prior to Screening and TSH criteria are met.
- History of or current signs of gastroparesis.
- Previous surgical procedure for obesity within 6 months prior to Check-in.
- 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 or allergy to AMG 133 or its ingredients, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- Estimated glomerular filtration rate less than ≤ 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation at Screening or Check-in. One repeat of abnormal values will be allowed.
- Alanine aminotransferase or aspartate aminotransferase > 2x the upper limit of normal at Screening or Check-in. One repeat of abnormal values will be allowed.
- History of or current suicidal ideation (thoughts), suicide attempt(s), or major psychiatric illness (including depression) within 6 months prior to Screening.
- 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, GIPR 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 (e.g., 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 Sponsor.
- Female participants of childbearing potential with a positive pregnancy test assessed at Screening or Check-in by a serum or urine pregnancy test.
- Female participants lactating/breastfeeding or who plan to breastfeed during the study through 16 weeks after the last dose of AMG 133.
- Unwilling to adhere to contraceptive requirements through 16 weeks after the last dose of AMG 133.
- 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 AMG 133 or have previously received the investigational product.
- Unwilling to abide with study restrictions.
- Participants who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CenExel
Anaheim, California, 92801
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247
CenExel Collaborative Neuroscience Research, LLC Los Alamitos
Los Alamitos, California, 90720
About this study
Official title: A Phase 1, Randomized, Double-blind, Multiple-dose Study to Evaluate the Pharmacokinetics of AMG 133 Administered Subcutaneously in Subjects With Overweight or Obesity
The primary objective of this study is to assess the pharmacokinetics (PK) of AMG 133 after multiple subcutaneous (SC) administrations in participants with overweight or obesity using various dose regimens.
- Conditions
- Overweight, Obesity
- Being tested
- AMG 133
- Keywords
- Overweight, Obesity, Maridebart cafraglutide, AMG 133
- 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
AMG 133 will be administered SC. Dose levels range from A to D lowest to highest.
| Study group | Role | What they receive |
|---|---|---|
| AMG 133 Dose A | Experimental | Participants will receive AMG 133 Dose A SC, followed by subsequent doses of Dose C and Dose D. Receives: Drug: AMG 133 |
| AMG 133 Dose B | Experimental | Participants will receive AMG 133 Dose B SC, followed by subsequent doses of Dose C and Dose D. Receives: Drug: AMG 133 |
| AMG 133 Dose C | Experimental | Participants will receive AMG 133 Dose C SC, followed by subsequent doses of Dose C and Dose D. Receives: Drug: AMG 133 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax) of AMG 133
Measured: Up to Day 99
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133
Measured: Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133
Measured: Day 29
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of AMG 133
Measured: Day 1 and Day 15
Secondary outcomes (3)
Number of Participants Who Experience Treatment-emergent Adverse Events
Measured: Up to Day 99
Number of Participants Who Experience Serious Adverse Events
Measured: Up to Day 99
Number of Participants Who Develop Anti-AMG 133 Antibodies
Measured: Up to Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 Aug 2024
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT06976372
- Sponsor's protocol ID
- 20240195
- Status last verified
- Oct 2025
- First submitted
- 9 May 2025
- Last updated
- 8 Oct 2025
- 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Multiple-dose Study to Evaluate the Pharmacokinetics of AMG 133 Administered Subcutaneously in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06976372
- Acronym / sponsor ID
- 20240195
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Maridebart cafraglutide, AMG 133
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 16 May 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 primary objective of this study is to assess the pharmacokinetics (PK) of AMG 133 after multiple subcutaneous (SC) administrations in participants with overweight or obesity using various dose regimens.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMG 133 Dose A | Experimental | Drug: AMG 133Participants will receive AMG 133 Dose A SC, followed by subsequent doses of Dose C and Dose D. |
| AMG 133 Dose B | Experimental | Drug: AMG 133Participants will receive AMG 133 Dose B SC, followed by subsequent doses of Dose C and Dose D. |
| AMG 133 Dose C | Experimental | Drug: AMG 133Participants will receive AMG 133 Dose C SC, followed by subsequent doses of Dose C and Dose D. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Male or female participants, between 18 and 65 years of age (inclusive) at the time of Screening.
- Except for obesity, no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee). Participants with obstructive sleep apnea, controlled hypertension, and/or controlled dyslipidemia on stable therapies will be permitted. Participants with other mild, well-controlled comorbidities may be permitted with approval of the Investigator (or designee) in consultation with the Medical Monitor as appropriate.
- Body mass index ≥ 27 kg/m^2 at the time of Screening.
- Have a stable body weight (< 5 kg self-reported change) within 3 months before Screening, as assessed by the Investigator (or designee) based on participant self-report. Have not modified diet or adopted any nutritional lifestyle modification for 3 months, as assessed by the Investigator (or designee) based on participant self-report.
Key exclusion criteria (25 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 gestational diabetes), or Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol), at Screening.
- History or evidence of endocrine disorder (such as 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 (> 2x the upper limit of normal) at Screening, or fasting serum triglyceride level of > 500 mg/dL at Screening. One repeat of abnormal values will be allowed.
- 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 |
|---|---|---|
| AMG 133AMG 133 will be administered SC. Dose levels range from A to D lowest to highest. | Drug | AMG 133 Dose A, AMG 133 Dose B, AMG 133 Dose C |
Primary outcome
Maximum Concentration (Cmax) of AMG 133
Time frame: Up to Day 99
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133
Time frame: Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133
Time frame: Day 29
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of AMG 133
Time frame: Day 1 and Day 15
3 secondary outcomes
Number of Participants Who Experience Treatment-emergent Adverse Events
Time frame: Up to Day 99
Number of Participants Who Experience Serious Adverse Events
Time frame: Up to Day 99
Number of Participants Who Develop Anti-AMG 133 Antibodies
Time frame: Up to Day 99
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 8 Oct 2025.
- 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.
Related trials for Overweight
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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
3 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 3 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 5 inclusion and 25 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Concentration (Cmax) of AMG 133 (time frame: Up to Day 99). The study lists 4 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 8 Oct 2025.