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Behavioural Intervention
NG101 for Obesity
Phase 2
Waitlist Available
Research Sponsored by Neurogastrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adult
Be between 18 and 65 years old
Must not have
History of presence of gastroparesis, gallbladder disease, acute or chronic pancreatitis, or surgery of the abdomen
History or presence of Type 1 or Type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours following glp-1 agonist injection
Summary
"This trial will enroll adults with a specific range of body mass index (BMI) and randomly assign them to receive either NG101 or a placebo for 5 days. On the second day, all participants
Who is the study for?
This trial is for adults with a BMI of 22-35 kg/m2 who are generally healthy but may be overweight. Participants will need to stay at the research unit during the treatment and can't have any health conditions that would interfere with the study or make it unsafe for them.
What is being tested?
The trial tests NG101's safety and effectiveness in reducing gastrointestinal side effects when taken with a GLP-1 agonist, semaglutide, compared to a placebo. It involves taking NG101 or placebo pills for five days and one injection of semaglutide on the second day.
What are the potential side effects?
Potential side effects include those related to GI issues since GLP-1 agonists often cause such problems. Specific side effects from NG101 aren't detailed here, but adverse events will be monitored throughout.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had gastroparesis, gallbladder issues, pancreatitis, or abdominal surgery.
Select...
I have a history of Type 1 or Type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 hours following glp-1 agonist injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 hours following glp-1 agonist injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of GI-related adverse events
Severity of GI-related adverse events
Secondary study objectives
Number of TEAEs of GI-related adverse events
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NG101 20 mg BIDExperimental Treatment2 Interventions
NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
Group II: PlaceboPlacebo Group2 Interventions
Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NG101
2024
Completed Phase 2
~290
Semaglutide Injectable Product
2024
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Neurogastrx, Inc.Lead Sponsor
1 Previous Clinical Trials
162 Total Patients Enrolled
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