Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500429
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist
Sponsor:
Neurogastrx Inc
Organization:
Neurogastrx Inc
Study Overview
Official Title:
A Proof-of-Concept Randomized Double-blind Placebo-controlled Study to Investigate the Safety and Efficacy of Oral NG101 in the Treatment of Side Effects in Healthy Adult Participants Administered a Single Subcutaneous Dose of a Glucagon-Like Peptide 1 Agonist
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adult participants with BMI between 22 - 35 kgm2 will be enrolled and randomized to receive either NG101 20 mg BID or placebo for 5 days beginning on Day 1 On Day 2 all participants will receive a single subcutaneous injection of a GLP-1 agonist semaglutide Participants will remain at the clinical research unit for the duration of the treatment period
The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo when also administered along with a GLP-1 agonist in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity Adverse event information will be collected GI-specific questionnaires will be used to capture additional details if GI-related adverse events are reported
The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo when also administered along with a GLP-1 agonist in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity Adverse event information will be collected GI-specific questionnaires will be used to capture additional details if GI-related adverse events are reported
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None