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Overweight and ObesityPhase 1NCT07717814

A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity

A Phase 1 study testing AMG 133 (frozen liquid) and AMG 133 (liquid) in people with Overweight and Obesity, run by Amgen at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered as a single subcutaneous (SC) dose using a liquid drug product in vial compared to a frozen liquid drug product in vial in participants living with overweight or obesity. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
AMG 133 (frozen liquid) and AMG 133 (liquid)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
4 sitesUnited States
Study dates
26 Nov 2024to 2 Jun 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Provide signed and dated informed consent before any study procedures.
  • Be male or female, 18 to 65 years old, at screening.
  • May have well-controlled conditions such as obstructive sleep apnea, high blood pressure, high cholesterol, or hypothyroidism on stable treatment for ≥ 3 months. Other mild, stable health conditions may be allowed with investigator and medical monitor approval.
  • Body mass index (BMI) between 25 and 40 kg/m² at screening.
  • Stable body weight (less than 5 kg change by self-report) during the 3 months before screening.
  • No major changes in diet or lifestyle (such as new weight-loss or exercise programs) during the past 3 months.

Who cannot join

  • Any significant medical condition or abnormal test result that could increase risk or interfere with study participation, based on investigator judgment.
  • Diabetes (any type except past gestational diabetes) or Hemoglobin A1c (HbA1c) ≥ 6.5%.
  • Endocrine disorders that can cause obesity (for example, Cushing's syndrome).
  • Pancreatitis within the past year, or abnormal pancreatic blood tests (lipase/amylase > 2 × normal) or fasting triglycerides > 500 mg/dL.
  • Cancer within 5 years (except treated non-melanoma skin cancer or in-situ cervical/breast lesions).
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
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  • Uncontrolled thyroid disease (thyroid stimulating hormone [TSH] > 6.0 or < 0.4 mIU/L). Participants on stable thyroid-replacement therapy for ≥ 3 months may be included if TSH is in range.
  • History or current signs of gastroparesis (delayed stomach emptying).
  • Weight-loss surgery within 6 months before check-in.
  • Heart or blood-vessel disease (aside from controlled high blood pressure or cholesterol), such as heart attack, angina, valve disease, or prior bypass/stent.
  • Clinically significant abnormal heart rhythm on electrocardiogram (ECG) at screening or check-in.
  • QT corrected for heart rate using Fridericia's method (QTcF) > 450 ms (males) or > 470 ms (females), or a history of long QT syndrome.
  • Second- or third-degree heart block.
  • Blood pressure > 150/95 mmHg or < 90/50 mmHg, or pulse > 110 bpm. A single repeat is allowed if values normalize.
  • Allergy or hypersensitivity to AMG 133 or its ingredients.
  • Poor veins for blood draws.
  • Kidney function (estimated glomerular filtration rate [eGFR]) ≤ 60 mL/min/1.73 m^2.
  • Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 2X normal.
  • Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) (exceptions apply for prior vaccination or resolved hepatitis B virus [HBV] infection).
  • Current or recent (within 6 months) suicidal thoughts, suicide attempts, or major psychiatric illness, including depression.
  • Use of any prescription or over-the-counter medicines within 30 days or 5 half-lives (whichever is longer) before check-in, except:
  • Acetaminophen ≤ 2 g/day for pain
  • Hormone replacement (e.g., estrogen, thyroid) or hormonal contraception
  • Stable treatments (≥ 3 months) for high blood pressure, high cholesterol, or other mild, well-controlled conditions approved by the investigator and medical monitor.
  • Use of any glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist/antagonist within 3 months.
  • Use of herbal medicines, vitamins, or supplements within 30 days, unless approved by the investigator and sponsor.
  • Consumption of poppy-seed-containing foods within 7 days before check-in.
  • Alcohol abuse or regular intake > 21 units/week (men) or > 14 units/week (women), or drug abuse within 1 year. (1 unit = 12 oz beer, 1.5 oz liquor, 5 oz wine.)
  • Alcohol use within 48 hours before check-in, or unwillingness to limit alcohol to ≤ 1 unit/day from discharge through study end.
  • Strenuous exercise or a new exercise program within 7 days before check-in.
  • Positive drug screen or tetrahydrocannabinol (THC) test, or unwillingness to avoid illicit drugs/THC through end of study.
  • Positive pregnancy test at screening or check-in.
  • Breastfeeding, or planning to breastfeed within 16 weeks after receiving AMG 133.
  • Men and women unwilling to use required contraception through 16 weeks after receiving AMG 133.
  • Men unwilling to abstain from sperm donation or women unwilling to abstain from egg donation through 16 weeks after receiving AMG 133.
  • Men with female partners of childbearing potential unwilling to inform their partner and adhere to contraception requirements.
  • Men with pregnant partners (or partners planning pregnancy) unwilling to use effective contraception or abstain from intercourse through 16 weeks after receiving AMG 133.
  • Participation in another investigational drug study within 30 days or 5 half-lives (whichever is longer).
  • Previous participation in any study of AMG 133.
  • Blood donation within 3 months, plasma within 2 weeks, or platelets within 6 weeks before check-in.
  • Unwillingness to follow study requirements or restrictions.
  • Any other reason, in the investigator's opinion, that makes participation unsuitable.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Fortrea Clinical Research Unit - Dallas

    Dallas, Texas, 75247

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach, Florida, 32117-5116

  • Fortrea Clinical Research Unit Inc. - Madison

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-label, Single-dose, Parallel Group Study to Assess the Relative Bioavailability of AMG 133 Administered Using One of Three Drug Products in Participants Living With Overweight or Obesity

The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered as a single subcutaneous (SC) dose using a liquid drug product in vial compared to a frozen liquid drug product in vial in participants living with overweight or obesity.

Being tested
AMG 133 (frozen liquid), AMG 133 (liquid)
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 133 (frozen liquid)Drug

    Also called Maridebart cafraglutide

    AMG 133 will be administered as a SC injection.

  • AMG 133 (liquid)Drug

    Also called Maridebart cafraglutide

    AMG 133 will be administered as a SC injection.

Study groups in NCT07717814
Study groupRoleWhat they receive
Group 1 (reference): AMG 133 Concentration A (frozen liquid)ExperimentalParticipants will receive a single dose of AMG 133 as a SC injection.
Receives: Drug: AMG 133 (frozen liquid)
Group 2 (test): AMG 133 Concentration B (liquid)ExperimentalParticipants will receive a single dose of AMG 133 as a SC injection.
Receives: Drug: AMG 133 (liquid)
Group 3 (test): AMG 133 Concentration C (liquid)ExperimentalParticipants will receive a single dose of AMG 133 as a SC injection.
Receives: Drug: AMG 133 (liquid)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax) of AMG 133

    Measured: Up to Day 120

  2. Area Under the Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133

    Measured: Up to Day 120

  3. AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133

    Measured: Up to Day 120

Secondary outcomes (3)

  1. Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

    Measured: Day 1 to Day 120

  2. Number of Participants who Experienced Serious AEs (SAEs)

    Measured: Screening to Day 120 (up to 148 days)

  3. 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.

  1. First posted21 Jul 2026
  2. Study start26 Nov 2024
  3. Primary completion22 May 2025
  4. Study completion2 Jun 2025

Resources

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
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717814
Sponsor's protocol ID
20210205
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
21 Jul 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 133 (frozen liquid) and AMG 133 (liquid) 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 6 inclusion and 42 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 21 Jul 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?

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?

On the ClinicalTrials.gov record for NCT07717814.

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 21 Jul 2026.

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