GV101 in Healthy Obese Participants

NCT06979505 | Completed Phase 2 FDA Drug

• 1 other identifier: GBS-201
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 20

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.

Conditions

Weight Management

Outcome Measures

Primary Outcomes (1)

• Mean percent change in body weight from baseline at Week 16 in each treated group as compared with placebo

  16 weeks

Study Arms (3)

GV101 low dose

EXPERIMENTAL

Drug: GV101

GV101 high dose

EXPERIMENTAL

Drug: GV101

GV101 matched placebo

PLACEBO COMPARATOR

Drug: GV101 placebo

Interventions

GV101 DRUG

GV101 suspension

GV101 high dose; GV101 low dose

GV101 placebo DRUG

GV101 placebo suspension

GV101 matched placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating.
• History of significant allergic reaction (e.g., immediate hypersensitivity, significant respiratory and skin symptoms such as Steven Johnson syndrome) or hypersensitivity to any drug.
• Clinically significant physical examination abnormalities or clinically significant laboratory abnormalities at screening.
• Obesity induced by other endocrinologic disorder (e.g., Cushing's syndrome).
• 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.
• 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).
• 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 trial).
• 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.
• History of clinically significant QTcF interval prolongation, or a QTcF interval of \> 470 ms in females or of \> 450 ms in males at screening.
• Clinically significant vital sign abnormalities at screening (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.
• 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.
• 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 longer, 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.
• Not willing to refrain from strenuous exercise or vigorous activity (e.g., heavy lifting, weight training, yard work in hot weather, and aerobics) for 72 hours before each blood collection for clinical laboratory tests.
• 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 and have a narrow therapeutic index.
• The following test results:

Sponsors & Collaborators

• Graviton Bioscience Corporation: lead

Study Sites (20)

Lakeview Clinical Research, LLC

Guntersville, Alabama, 35976, United States

Location

Arizona Clinical Trials

Tucson, Arizona, 85712, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, 40213, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Study Metrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Mercury Street Medical

Butte, Montana, 59701, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58104, United States

Location

Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research - Dallas

Dallas, Texas, 75230, United States

Location

Advanced Research Institute - Ogden

Ogden, Utah, 84405, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Hadassah Medical Center Ein Karem

Jerusalem, Israel, Israel

Location

Hasharon Hospital

Petah Tikva, Israel, Israel

Location

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel, Israel

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1:1 random assignment to GV101 low dose, high dose, or matched placebo

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 30, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (16); IL (4)