Clinical trial NCT06979505: GV101 in Healthy Obese Participants
Official title: Dose-ranging Double-blind, Placebo-controlled Phase 2 Trial of GV101 for Weight Loss in Healthy Obese Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Weight Management
Lead sponsor: Graviton Bioscience Corporation
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 random assignment to GV101 low dose, high dose, or matched placebo
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the efficacy and safety of GV101 for weight loss over a range of doses in participants with obesity. The primary efficacy endpoint is the mean percent change in body weight from baseline at Week 16 in each treated group as compared with placebo.


Eligibility criteria: Inclusion Criteria:

1. 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.
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 or medically qualified designee based on a medical evaluation including medical history, 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 (those recommended via lifestyle counseling are acceptable).
6. Participants of reproductive potential (any male who has not undergone vasectomy more than 6 month prior to the first dose of 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 post-menopausal \[age ≥ 55 years with amenorrhea for \> 1 year without a separate identifiable cause and a medical history consistent with menopause\]), 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)
7. 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.
8. Male participants must agree not to donate sperm until 90 days after the last dose of IMP.

Exclusion Criteria:

1. Pregnant or lactating.
2. History of significant allergic reaction (e.g., immediate hypersensitivity, significant respiratory and skin symptoms) or hypersensitivity to any drug.
3. History of clinically significant gastrointestinal disease or surgery that may affect IMP absorption. A history of appendectomy or cholecystectomy is not exclusionary.
4. Clinically significant physical examination abnormalities or clinically significant laboratory 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 \> 1 year before trial entry) and/or participants with recent (within 6 months) or planned endoscopic treatment for obesity.
7. Current or history (within 90 days before screening) of treatment with medications that may cause significant weight gain or loss, including systemic corticosteroids (except for a short course of treatment, i.e., 7 - 10 days), tricyclic antidepressants, 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 reduction program 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 insulinotropic polypeptide (GIP) agonists (either by prescription or as part of a clinical study).
9. Evidence of clinically significant hepatic or renal impairment, including but not limited to screening test results of ALT and AST above 1.5x the ULN, total bilirubin above the ULN, history of Gilbert's syndrome or of elevated bilirubin, especially while 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 during the screening period (systolic blood pressure \[SBP\] \< 90 or \> 150 mm Hg, diastolic blood pressure \[DBP\] \< 50 or \> 100 mm Hg, or heart rate \[HR\] \< 50 or \> 100 bpm). Retesting is allowed at the discretion of the site Investigator or designee.
12. Not willing to limit alcohol consumption to 2 drinks per day for males and 1 drink per day for females. History of alcohol misuse within 1 year prior to screening or regular alcohol consumption (more than 14 units per week \[1 unit = 150 mL wine, 360 mL beer, or 45 mL 40% alcohol\]) within 6 months prior to the screening visit.
13. History of illicit drug misuse within 1 year prior to screening, or use of hard drugs (e.g., cocaine, phenylcyclohexyl piperidine \[PCP\], crack, opioid derivatives, and amphetamine derivatives) within 1 year prior to screening. A history of marijuana or tetrahydrocannabinol (THC)- product use within 90 days of enrollment or unwillingness to abstain from marijuana or the use of THC-containing products during the trial is also exclusionary.
14. Participation in a clinical trial involving the administration of an investigational or marketed drug or device use within 30 days or 5 half-lives, whichever is shorter, before IMP administration; administration of a biological product in the context of a clinical trial within 90 days or 5 half-lives before IMP administration, whichever is longer, or concurrent participation in an experimental trial that does not involve the administration of an IMP or device use.
15. Not willing to refrain from strenuous exercise (e.g., heavy lifting, weight training, and aerobics) for 72 hours before each blood collection for clinical laboratory tests.
16. Use of drugs and foods including CYP3A4 inhibitors or inducers (Table 10), UGT1A1 substrates and inhibitors, daily use of medications that are substrates of CYP2C8, CYP2C9, or CYP2C19.
17. The following test results:

    1. Positive hepatitis B, hepatitis C, or HIV test at screening
    2. Calculated estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 at screening
    3. Positive pregnancy test at any time from screening onwards
    4. Positive drug test at screening
    5. Positive cotinine test at screening
    6. HbA1c ≥ 6.5% and/or known history of type 1 or type 2 diabetes mellitus, other forms of diabetes like LADA, MODY and secondary diabetes.

       Note: Patients with h/o gestational diabetes (but no diagnosis of T2DM post partum) can qualify.
    7. Thyroid stimulating hormone (TSH) \> 6 mIU/L or \< 0.4 mIU/L at screening
    8. Fasting triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL)
    9. ALT or AST above 1.5x the ULN, total bilirubin above the ULN at screening
18. Use of nicotine or tobacco-containing products (including but not limited to snuff, chewing tobacco, cigars, cigarettes, e-cigarettes/vaping, pipes, or nicotine patches) within 6 months of screening. Participant unwilling or unable to abstain from using nicotine or tobacco, cigars, cigarettes, e-cigarettes/vaping, pipes, or nicotine patches throughout the course of the trial.
19. History or evidence of any other clinically significant disorder, condition, or disease 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.

Primary outcomes:
measure: Mean percent change in body weight from baseline at Week 16 in each treated group as compared with placebo
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: