130 Participants Needed

GV101 for Obesity

Recruiting at 18 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I will use a condom during the trial if my partner is pregnant.
I am willing and able to follow all trial procedures and attend all visits.
My weight has been stable, with less than a 3 kg change in the last 3 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GV101 or placebo for weight loss over a range of doses

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GV101
Trial Overview GV101 is being tested for its effectiveness in helping with weight loss compared to a placebo over 16 weeks. Participants will be given different doses of GV101 or a placebo to see which works best.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: GV101 low doseExperimental Treatment1 Intervention
Group II: GV101 high doseExperimental Treatment1 Intervention
Group III: GV101 matched placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Graviton Bioscience Corporation

Lead Sponsor

Trials
1
Recruited
20+
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