GV101 in Healthy Obese Participants

Who may be able to join

• Male or female, aged ≥ 18 years and ≤ 70 years with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 at the time of informed consent.
• Willing and able to provide written informed consent to participate in the trial, available for all visits, and able and willing to comply with all trial procedures.
• 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 at screening.
• Have a stable body weight (< 3 kg self-reported change during the previous 90 days) before screening.
• Willing to refrain from drastic changes in diet and physical activity regimen (those recommended via lifestyle counseling are acceptable).
• Participants of reproductive potential (any male who has not undergone vasectomy more than 6 months prior to the first dose of investigational medicinal product [IMP] and any female who has not undergone bilateral oophorectomy, hysterectomy, total abdominal hysterectomy with bilateral salpingo-oophorectomy, bilateral tubal occlusion or ligation or who is not postmenopausal (a. A woman ≥55 years old not on hormone therapy, with amenorrhea for ≥12 months without an alternative medical cause, or b. A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy or c. A woman > 40 and < 55 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least r1 year without an alternative cause, AND a follicle-stimulating hormone (FSH) >25 mIU/mL or d. A woman with premature ovarian failure confirmed by historical FSH levels in the postmenopausal range prior to initiating HRT, or by a documented irreversible medical condition causing permanent infertility.)), who are heterosexually active, must agree to use a combination of two of the following methods of contraception (males must ensure their partner(s) use at least one method below to ensure at least two contraceptive methods are in place and must continue with this contraceptive plan for 90 days after the last dose of IMP; females must continue with this contraceptive plan for 28 days)
• Male participants with a pregnant partner (including those who have undergone a vasectomy) must agree to use a condom from the first dose of the IMP administration until at least 90 days after the last (if applicable) dose of the IMP.
• Male participants must agree not to donate sperm until 90 days after the last dose of IMP.