| Eligibility |
Inclusion Criteria:
- Provide signed informed consent.
- Participants must be of Chinese ancestry with biological parents and all 4
grandparents of Chinese ancestry.
- Male or female participants, between 18 and 65 years of age (inclusive) at the time of
Screening. Female participants must be of nonchildbearing potential.
- Except for obesity, no clinically significant findings from medical history (that
requires the use of medications and/or treatment), physical examination, 12-lead
electrocardiogram (ECG), vital signs measurements, and clinical laboratory
evaluations.
- Body mass index between 24 and 40 kg/m^2 (inclusive) at the time of Screening.
- Have a stable body weight (<5 kg self-reported change) within 3 months before
Screening.
- Have not modified diet or adopted any nutritional lifestyle modification for 3 months.
Exclusion Criteria:
- 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 or evidence, at Screening, of diabetes (regardless of type), based on
Hemoglobin A1C of > 7%.
- History or evidence of endocrine disorder (such as Cushing's Syndrome) that can cause
obesity.
- Previous surgical procedure for obesity (excluding liposuction if performed >1 year
before study entry) within past 6 months from Check-in.
- History or current signs or symptoms of cardiovascular disease.
- History of clinically significant hypersensitivity, intolerance, or allergy to any
drug compound, food, or other substance, unless approved by the Investigator (or
designee) and in consultation with the Sponsor.
- Estimated glomerular filtration rate less than at least 60 mL/min/1.73 m^2 at
Screening or Check-in.
- Alanine aminotransferase or aspartate aminotransferase >2 x the upper limit of normal
at Screening or Check-in.
- Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus
test at Screening. Participants whose results are compatible with prior immunity
(vaccination or prior infection) may be included.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives
(whichever is longer) before Check-in.
1. Acetaminophen (paracetamol; up to 2 g per day) for analgesia will be allowed.
2. Hormone replacement therapy (eg, estrogen, thyroid) will be allowed.
- Current or prior use of any glucagon-like peptide 1 agonist within the past 3 months
prior to Check-in.
- All herbal medicines (eg, St. John's wort), Traditional Chinese Medicine herbs or
formulations, 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.
- History of alcoholism or regular alcohol consumption of >14 units per week for males
and >7 units for females or drug/chemical abuse within 1 year prior to Check-in.
- Alcohol consumption from 48 hours prior to Check-in and is unwilling to limit alcohol
intake to a maximum of 1 unit/day on all other days, while not in the clinical
research unit, from Screening through the End of Study (EOS) visit.
- Use of tobacco- or nicotine-containing products within 6 months prior to Check-in.
- Female participants with a positive pregnancy test at Screening or Check-in.
- Female participants lactating/breastfeeding or who plans to breastfeed during the
study through 90 days after the EOS visit.
- Unwilling to adhere to contraceptive requirements through 90 days after the EOS visit.
- Male participants with a female partner of childbearing potential and not willing to
inform his partner of his participation in this clinical study.
- Pregnant partner (of a male participant) or partner planning to become pregnant who is
unwilling to practice abstinence (refrain from heterosexual intercourse) or use
contraception while the participant is on study through 90 days after the EOS visit.
- Participant has received a dose of an investigational drug within the past 90 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.
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