Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity

Completed · Phase 1 · Has a placebo group

Conditions studied: Obesity

In brief

The study aims to assess the safety and tolerability of maridebart cafraglutide as single and multiple doses in participants with obesity

Key facts

Study ID: NCT04478708
Run by: Amgen
People needed: 110
Starts: 2020-08-07
Expected to finish: 2022-11-18
Last updated by the study team: 2025-12-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years to ≤ 65 years, at the time of signing the informed consent.
Except for obesity, otherwise healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and ECGs on day -2 (cohorts 1-6, cohort 11-13) or day -1 (cohorts 7-10) and screening.
Body mass index between ≥ 30.0 kg/m\^2 and ≤ 40.0 kg/m\^2.
Have a stable body weight (< 5 kg self-reported change during the previous 8 weeks) before screening.
Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 hours before each blood sample collection for the clinical laboratory analysis, which should not be strenuous.
Females must be of nonreproductive potential
Postmenopausal as defined as:
Age of ≥ 55 years with no menses for at least 12 months; OR
Age < 55 years with no menses for at least 12 months AND with a follicle-stimulating hormone level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR
History of hysterectomy; OR
History of bilateral oophorectomy.
For patients in cohorts 7-10 only, participants must have a smartphone device with the capability of downloading apps or other digital tools required for this cohort.

You may not qualify if…

History or clinical evidence of diabetes mellitus, including hemoglobin A1c (HbA1c) > 6.5% and/or a fasting glucose ≥ 125 mg/dl (6.9 mmol/L) at screening.
Triglycerides ≥ 5.65 mmol/L (ie, 500 mg/dL) at screening.
Screening calcitonin ≥ 50 ng/L.
Hepatic liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at screening. If ALT is > 1.5 x the ULN at screening AND the AST, alkaline phosphatase, and total bilirubin levels are within normal limits, then participant may be eligible for enrollment after a discussion with the medical monitor.
History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (PTT), international normalized ratio (INR), or platelet count outside of the laboratory's normal reference range at screening. If a single value (PT, PTT, INR, or platelet count) is outside the normal reference range at screening and the participant does not have evidence of any other bleeding or coagulation disorder, then the participant may be eligible for enrollment after a discussion with the medical monitor.
History of gastrointestinal abnormality that could affect gastrointestinal motility (including small bowel or colonic resection, inflammatory bowel disease, irritable bowel disease, and colon or gastrointestinal tract cancer).
Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.
Participants with a history of confirmed chronic pancreatitis or idiopathic acute pancreatitis.
Participants with a history of gall bladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy.
Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid stimulating hormone > 6 mIU/L or <0.4 mIU/L.
A corrected QT interval (QTc) at screening of > 450 msec in males or > 470 msec in females or history of long QT syndrome.
Participants with a history of renal impairment or renal disease and/or estimated glomerular filtration rate ≤ 60 mL/min/1.73 m\^2.
Obesity induced by other endocrinologic disorders (eg, Cushing's Syndrome).
Previous surgical treatment for obesity (excluding liposuction if performed >1 year before study entry) and/or participants with recent (within 6 months) or planned endoscopic treatment for obesity.
History of major depressive disorder.
History of other severe psychiatric disorders, eg schizophrenia, bipolar disorder.
Any lifetime history of a suicidal attempt or of any suicidal behavior.
Surgery scheduled for the study duration period, except for minor surgical procedures, at the discretion of the investigator.
Positive results for human immunodeficiency virus antibodies, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus RNA. For hepatitis C, hepatitis C antibody testing is done at screening, followed by hepatitis C virus RNA by polymerase chain reaction if hepatitis C antibody is positive.
Systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg at screening, or on day -2. For each visit, if the initial blood pressure is elevated, the reading may be repeated once at least 15 minutes later and the lower of the 2 readings may be used.
History of malignancy of any type, other than in situ cervical cancer or surgically excised nonmelanomatous skin cancers occurring more than 5 years before randomization.
Use of the following agents are excluded unless there is a prior consultation between the investigator and Amgen medical monitor:
Prescription and nonprescription drugs within 14 days or 5 half-lives, whichever is longer, before the first dose of investigational product, with exception of hormone replacement therapy (eg, estrogen, thyroid).
All herbal medicines, vitamins, and supplements within 30 days before receiving the first dose of investigational product.
Exceptions must be reviewed and approved by the investigator and Amgen medical monitor. Written documentation of this review and Amgen acknowledgment is required for participant participation.

Where it is running

Anaheim Clinical Trials — Anaheim, California, United States
Orange County Research Center — Tustin, California, United States
Clinical Pharmacology of Miami, LLC — Miami, Florida, United States

Full record on ClinicalTrials.gov

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