GV101 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called GV101, a potential weight loss drug, to help people with obesity lose weight safely and effectively. Researchers aim to determine how well different doses of GV101 work compared to a placebo (a non-active substance) over 16 weeks. Suitable candidates for this trial have been living with obesity (BMI of 30 or higher), are otherwise healthy, and haven't experienced major weight changes recently. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot be on medications that cause significant weight changes or certain other drugs like those affecting liver enzymes. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that GV101 is likely to be safe for humans?
Research has shown that GV101 has been tested in healthy individuals to assess its safety and tolerability. A study on GV101 found it was generally well-tolerated at various doses, with most participants experiencing no serious side effects. Some mild side effects occurred, but they were uncommon.
GV101 is now in a Phase 2 trial for obesity, indicating existing evidence of its safety from earlier studies. Drugs reaching this phase have typically passed initial safety tests. However, each trial continues to gather more data on its efficacy and safety at different doses.
For those considering trial participation, GV101 has demonstrated promising safety results so far. Nonetheless, ongoing monitoring is essential to ensure its continued safety.12345Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about GV101 for obesity because it offers a new approach compared to standard treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Unlike these existing options, GV101 is unique as it is administered in both low and high doses to assess its effectiveness, potentially allowing for more personalized treatment plans. Additionally, GV101 might target specific pathways related to obesity that are not addressed by current treatments, providing a novel mechanism of action that could lead to more effective weight management solutions.
What evidence suggests that GV101 might be an effective treatment for obesity?
Research shows that GV101 works by blocking a protein called ROCK2, which influences inflammation and metabolism. This mechanism might aid weight loss, as these processes often link to obesity. Early results suggest GV101 can help people lose weight, though exact weight loss figures are not yet available. In this trial, participants will receive either a low dose or a high dose of GV101, or a matched placebo, to determine the most effective dose. While GV101 shows promise for weight loss, further research is needed to confirm its efficacy.12356
Are You a Good Fit for This Trial?
This trial is for obese individuals who are otherwise healthy, have had a stable body weight in the past 3 months, and can follow the trial procedures. They must not plan to make drastic diet or exercise changes and agree to use contraception if of reproductive potential.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GV101 or placebo for weight loss over a range of doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GV101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Graviton Bioscience Corporation
Lead Sponsor