| Eligibility |
Inclusion Criteria:
- Male or female between 18-70 years of age, inclusive, at Screening
- BMI = 28 kg/m2 at Screening
- Diagnosis of insulin resistance based on HOMA-IR > 2.84 at Screening or a confirmed
diagnosis of type 2 diabetes mellitus
- Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall
within the protocol-defined ranges
- A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities
that are considered not clinically significant by the investigator
- Female subjects of childbearing potential must have a negative serum pregnancy test at
Screening and a negative urine pregnancy test on Day 1 prior to first dose of study
drug
- Male and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception
Exclusion Criteria:
- HbA1c > 10% at Screening
- Weight loss > 5% weight during the 90 days prior to Screening
- Pregnant or lactating subjects.
- Current alcohol abuse that is judged by the investigator to potentially interfere with
the subject's compliance or safety
- Current substance abuse that is judged by the investigator to potentially interfere
with the subject's compliance or safety
- A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B
(HBV) surface antigen, or hepatitis C (HCV) antibody
- Unstable cardiovascular disease as defined by any of the following: unstable angina
within 6 months prior to Screening; myocardial infarction, coronary artery bypass
graft surgery, or coronary angioplasty within 6 months prior to Screening; transient
ischemic attack or cerebrovascular accident within 6 months prior to Screening;
obstructive valvular heart disease or hypertrophic cardiomyopathy; congestive heart
failure (NYHA Class = 2); implanted defibrillator or pacemaker
- Medical history of liver disease, including but not limited to, alcoholic liver
disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing
cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,
clinically significant iron overload, or alpha-1-antitrypsin deficiency. A history of
nonalcoholic fatty liver disease (NAFLD), including hepatic steatosis or nonalcoholic
steatohepatitis (NASH) is permitted.
- History of intestinal resection or malabsorptive condition that may limit the
absorption of study drug
- Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric
acid hypersecretory conditions at Screening, in the opinion of the investigator
- Any scheduled surgery during the trial period, excluding minor surgical procedures
performed under local anesthesia, in the opinion of the investigator
- History of malignancy within 5 years prior to Screening except adequately treated
carcinoma in situ of the cervix, and/or squamous cell cancer, or other localized
non-melanoma skin cancer
- History of significant drug allergy, such as anaphylaxis or significant drug
sensitivity, in the opinion of the investigator
- Known hypersensitivity to study drug, its metabolites, or formulation excipients
- Presence of any medical condition that could, in the opinion of the investigator,
compromise the subject's ability to participate in the study, including a history of
substance abuse or a psychiatric disorder, including any subject with a psychiatric
hospital admission or emergency room visit in the 2 years prior to Screening
- Any laboratory abnormality that in the opinion of the investigator could adversely
affect the safety of the subject or impair assessment of study results
- Subjects on any oral medication with a narrow therapeutic window (e.g., warfarin,
digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline, and
anticonvulsants)
- Medications or therapies prescribed or taken over-the-counter for weight loss, in the
90 days prior to Screening.
- Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of
planned dosing of study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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