Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GLWL Research Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
PARTS A-C:
Non-vasectomized males (or those vasectomized less than 4 months prior to study start) must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug
Males agree to not donate sperm from dosing until 90 days after dosing
Laboratory test results within normal range or acceptable deviation, and Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) / Gamma Glutamyl Transferase (GGT) / Alkaline Phosphatase (ALP) to be less than or equal to (≤)1.5 x upper limit of normal (ULN), and total bilirubin has to be within normal limit
Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 60 milliliter (mL)/minute/1.73m2
No evidence of weight excursion beyond 5% of baseline weight within 3 months of screening
PART A Only:
Overtly healthy males or females, as determined by medical history and physical examination
Males must be 18 to 65 years old; females must be 40 to 65 years old
Female participants must be:
1. Women with prior history of hysterectomy who are at least 45 years of age and with follicle-stimulating hormone (FSH) greater than (\>) 40 milli-international units per milliliter (mIU/mL), or
2. Menopausal women with either: spontaneous amenorrhea for at least 12 months (not induced by a medical condition or medications); or spontaneous amenorrhea for 6 to 12 months and a FSH \> 40 mIU/mL
Body mass index (BMI) of 28 to 35 kilograms divided by height in meters squared (kg/m2)
Normotensive (supine systolic blood pressure (BP) less than (\<) 140 millimeter of mercury (mmHg) and diastolic BP \<90 mmHg
No evidence of weight excursion beyond 5% of baseline weight within 3 months of screening
PARTS B and C:
Must have Type 2 Diabetes Mellitus
Be 18 to 70 years old
Have BMI of 28 to 42 kg/m2
Female participants must be of non-childbearing potential, and must have undergone one of the following sterilization procedures at least 6 months prior to first dose: hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and with FSH serum levels consistent with postmenopausal status
Normotensive (supine systolic BP) \< 150 mmHg and diastolic BP \<95 mmHg or well-controlled hypertension while on a stable hypertensive
You may not be if
PARTS A-C:
Currently enrolled in a clinical trial or any other medical research judged to be not compatible with the study, or have participated in the last 30 days prior to dosing in a clinical trial involving an investigational product or non-approved use of a drug with short half-life, or within 5 half-lives of an investigational product with a half-life longer than 6 days
Abnormality in the 12-lead electrocardiogram (ECG) including corrected QT (QTc) interval with Bazett's correction \>450 milliseconds (msec) for men and \>470 msec for women, or an abnormality that, in the opinion of the Investigator, increases the risks associated with participating in the study
Significant cardiovascular disease or other disorders
Evidence of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or other chronic liver or biliary disease
Average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or is unwilling to stop use of Cytochrome P450 (CYP3A) inhibitors/inducers (St. John's Wort) or alcohol consumption for the study, or regular use of known drugs of abuse or positive finding on urinary drug screen, use of cigarettes or nicotine products within last 3 months, or blood donation or loss within 56 days prior to the study
Neuropsychiatric disease or pharmacological therapy for such conditions within 1 year of dosing, or antidepressants or antipsychotics within 3 months of dosing, or surgery within last 60 days
Eating disorder or weight loss medications within 4 months of dosing, or bariatric surgery
Unsuitable for inclusion in the study in the opinion of the investigator or sponsor
PART A Only:
History of hypertension (or on treatment with any antihypertensives)
Endocrine illness such as diabetes, growth hormone insufficiency / acromegaly, adrenal gland or thyroid illness
PARTS B and C:
Currently taking simvastatin \> 10 mg per day, or atorvastatin \> 20 mg per day, or lovastatin \>20 mg per day, or history of statin-induced myopathy / rhabdomyolysis. Participants taking any dose of simvastatin will be excluded from some cohorts
Allergic to the components of the Mixed Meal Tolerance Test
