COMPLETED

GV101 in Healthy Obese Participants

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dose-ranging Double-blind, Placebo-controlled Phase 2 Trial of GV101 for Weight Loss in Healthy Obese Participants

Quick Facts

Study Start:2025-06-30

Study Completion:2026-01-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06979505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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) 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.	1. Pregnant or lactating. 2. History of significant allergic reaction (e.g., immediate hypersensitivity, significant respiratory and skin symptoms such as Steven Johnson syndrome) 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 trial). 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 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. 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 30 days of enrollment and unwillingness to abstain from marijuana or the use of THC-containing products during the trial is also exclusionary. Stable daily CBD use is allowed (stable for \> 30 days prior to randomization and planned continued stable use throughout the trial). Intermittent CBD use is not allowed. 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 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. 15. 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. 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 and have a narrow therapeutic index. 17. The following test results: 1. Positive hepatitis B, positive hepatitis C Ab with non-negative HCV RNA test, or positive 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. 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. 6. Thyroid stimulating hormone (TSH) \> 6 mIU/L or \< 0.4 mIU/L at screening 7. Fasting triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) 8. ALT or AST above 1.5x the ULN, total bilirubin above the ULN at screening 9. Platelet count \< 150,000 platelets/mL 18. Participant unwilling or unable to abstain from using nicotine or tobacco, cigars, cigarettes, e-cigarettes/vaping, pipes, or nicotine patches for 45 minutes prior to trial visits. 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.

Inclusion Criteria

Exclusion 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 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)
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.

1. Pregnant or lactating.
2. History of significant allergic reaction (e.g., immediate hypersensitivity, significant respiratory and skin symptoms such as Steven Johnson syndrome) 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 trial).
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 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.
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 30 days of enrollment and unwillingness to abstain from marijuana or the use of THC-containing products during the trial is also exclusionary. Stable daily CBD use is allowed (stable for \> 30 days prior to randomization and planned continued stable use throughout the trial). Intermittent CBD use is not allowed.
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 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.
15. 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.
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 and have a narrow therapeutic index.
17. The following test results:
1. Positive hepatitis B, positive hepatitis C Ab with non-negative HCV RNA test, or positive 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. 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.
6. Thyroid stimulating hormone (TSH) \> 6 mIU/L or \< 0.4 mIU/L at screening
7. Fasting triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL)
8. ALT or AST above 1.5x the ULN, total bilirubin above the ULN at screening
9. Platelet count \< 150,000 platelets/mL
18. Participant unwilling or unable to abstain from using nicotine or tobacco, cigars, cigarettes, e-cigarettes/vaping, pipes, or nicotine patches for 45 minutes prior to trial visits.
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.

Contacts and Locations

Study Locations (Sites)

Lakeview Clinical Research, LLC

Guntersville, Alabama, 35976

United States

Arizona Clinical Trials

Tucson, Arizona, 85712

United States

Catalina Research Institute, LLC

Montclair, California, 91763

United States

Encompass Clinical Research

Spring Valley, California, 91978

United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, 40213

United States

Tandem Clinical Research

Marrero, Louisiana, 70072

United States

Study Metrix Research

City of Saint Peters, Missouri, 63303

United States

Kansas City Research Institute

Kansas City, Missouri, 64131

United States

Mercury Street Medical

Butte, Montana, 59701

United States

Hassman Research Institute

Berlin, New Jersey, 08009

United States

Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304

United States

Lillestol Research, LLC

Fargo, North Dakota, 58104

United States

Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122

United States

Velocity Clinical Research - Dallas

Dallas, Texas, 75230

United States

Advanced Research Institute - Ogden

Ogden, Utah, 84405

United States

Chrysalis Clinical Research

St. George, Utah, 84790

United States

Collaborators and Investigators

Sponsor: Graviton Bioscience Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30

Study Completion Date2026-01-28

Study Record Updates

Study Start Date2025-06-30

Study Completion Date2026-01-28

Terms related to this study

Additional Relevant MeSH Terms

Weight Management