GV101 in Healthy Obese Participants

Inclusion Criteria:

1. Male or female, aged ≥ 18 years and ≤ 70 years with BMI ≥ 30.0 kg/m2 and ≤ 45.0kg/m2 at the time of informed consent.

2. 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.

3. Except for obesity, otherwise healthy, as determined by the Investigator ormedically qualified designee based on a medical evaluation including medicalhistory, physical examination, laboratory tests, and ECGs at screening.

4. Have a stable body weight (< 3 kg self-reported change during the previous 90 days)before screening.

5. Willing to refrain from drastic changes in diet and physical activity regimen (thoserecommended via lifestyle counseling are acceptable).

6. Participants of reproductive potential (any male who has not undergone vasectomymore 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 tubalocclusion or ligation or who is not postmenopausal (a. A woman ≥55 years old not onhormone therapy, with amenorrhea for ≥12 months without an alternative medicalcause, or b. A woman at least 55 years of age with a diagnosis of menopause prior tostarting hormone replacement therapy or c. A woman > 40 and < 55 years of age withan intact uterus, not on hormone therapy, who has cessation of menses for at leastr1 year without an alternative cause, AND a follicle-stimulating hormone (FSH) >25mIU/mL or d. A woman with premature ovarian failure confirmed by historical FSHlevels in the postmenopausal range prior to initiating HRT, or by a documentedirreversible medical condition causing permanent infertility.)), who areheterosexually active, must agree to use a combination of two of the followingmethods of contraception (males must ensure their partner(s) use at least one methodbelow to ensure at least two contraceptive methods are in place and must continuewith this contraceptive plan for 90 days after the last dose of IMP; females mustcontinue with this contraceptive plan for 28 days)

7. Male participants with a pregnant partner (including those who have undergone avasectomy) must agree to use a condom from the first dose of the IMP administrationuntil at least 90 days after the last (if applicable) dose of the IMP.

8. Male participants must agree not to donate sperm until 90 days after the last doseof IMP.

Exclusion Criteria:

1. Pregnant or lactating.

2. History of significant allergic reaction (e.g., immediate hypersensitivity,significant respiratory and skin symptoms such as Steven Johnson syndrome) orhypersensitivity to any drug.

3. History of clinically significant gastrointestinal disease or surgery that mayaffect IMP absorption. A history of appendectomy or cholecystectomy is notexclusionary.

4. Clinically significant physical examination abnormalities or clinically significantlaboratory abnormalities at screening.

5. Obesity induced by other endocrinologic disorder (e.g., Cushing's syndrome).

6. Previous surgical treatment for obesity (excluding liposuction, if performed > 1year before trial entry) and/or participants with recent (within 6 months) orplanned endoscopic treatment for obesity.

7. Current or history (within 90 days before screening) of treatment with medicationsthat may cause significant weight gain or loss, including systemic corticosteroids (except for a short course of treatment, i.e., 7 - 10 days), tricyclicantidepressants, atypical antipsychotics and mood stabilizers (e.g., imipramine,amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine,clozapine, olanzapine, valproic acid and its derivatives, and lithium).

8. Current participation (or within the last 90 days) in an organized weight reductionprogram or currently using or used within 90 days before screening: pramlintide,sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion,lorcaserin, metformin, or any GLP-1R and/or glucose-dependent insulinotropicpolypeptide (GIP) agonists (either by prescription or as part of a clinical trial).

9. Evidence of clinically significant hepatic or renal impairment, including but notlimited to screening test results of ALT and AST above 1.5x the ULN, total bilirubinabove the ULN, history of Gilbert's syndrome or of elevated bilirubin, especiallywhile fasting.

10. History of clinically significant QTcF interval prolongation, or a QTcF interval of > 470 ms in females or of > 450 ms in males at screening.

11. Clinically significant vital sign abnormalities at screening (systolic bloodpressure [SBP] < 90 or > 150 mm Hg, diastolic blood pressure [DBP] < 50 or > 100 mmHg, or heart rate [HR] < 50 or > 100 bpm). Retesting is allowed at the discretion ofthe site Investigator or designee.

12. Not willing to limit alcohol consumption to 2 drinks per day for males and 1 drinkper day for females. History of alcohol misuse within 1 year prior to screening orregular alcohol consumption (more than 14 units per week [1 unit = 150 mL wine, 360mL beer, or 45 mL 40% alcohol]) within 6 months prior to the screening visit.

13. History of illicit drug misuse within 1 year prior to screening, or use of harddrugs (e.g., cocaine, phenylcyclohexyl piperidine [PCP], crack, opioid derivatives,and amphetamine derivatives) within 1 year prior to screening. A history ofmarijuana or tetrahydrocannabinol (THC)- product use within 30 days of enrollmentand unwillingness to abstain from marijuana or the use of THC-containing productsduring the trial is also exclusionary. Stable daily CBD use is allowed (stable for > 30 days prior to randomization and planned continued stable use throughout thetrial). Intermittent CBD use is not allowed.

14. Participation in a clinical trial involving the administration of an investigationalor marketed drug or device use within 30 days or 5 half-lives, whichever is longer,before IMP administration; administration of a biological product in the context ofa clinical trial within 90 days or 5 half-lives before IMP administration, whicheveris longer, or concurrent participation in an experimental trial that does notinvolve the administration of an IMP or device use.

15. Not willing to refrain from strenuous exercise or vigorous activity (e.g., heavylifting, weight training, yard work in hot weather, and aerobics) for 72 hoursbefore each blood collection for clinical laboratory tests.

16. Use of drugs and foods including CYP3A4 inhibitors or inducers (Table 10), UGT1A1substrates and inhibitors, daily use of medications that are substrates of CYP2C8,CYP2C9, or CYP2C19 and have a narrow therapeutic index.

17. The following test results:

18. Positive hepatitis B, positive hepatitis C Ab with non-negative HCV RNA test,or positive HIV test at screening

19. Calculated estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 atscreening

20. Positive pregnancy test at any time from screening onwards

21. Positive drug test at screening

22. HbA1c ≥ 6.5% and/or known history of type 1 or type 2 diabetes mellitus, otherforms of diabetes like LADA, MODY and secondary diabetes.Note: Patients with h/o gestational diabetes (but no diagnosis of T2DM postpartum) can qualify.

23. Thyroid stimulating hormone (TSH) > 6 mIU/L or < 0.4 mIU/L at screening

24. Fasting triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL)

25. ALT or AST above 1.5x the ULN, total bilirubin above the ULN at screening

26. Platelet count < 150,000 platelets/mL

27. Participant unwilling or unable to abstain from using nicotine or tobacco, cigars,cigarettes, e-cigarettes/vaping, pipes, or nicotine patches for 45 minutes prior totrial visits.

28. History or evidence of any other clinically significant disorder, condition, ordisease or any other reason that, in the opinion of the Investigator or physician,would pose a risk to participant safety or interfere with the trial evaluation,procedures, or completion.