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NCT06500429 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist
A Phase 2 study of Healthy and Overweight and Obesity, sponsored by Neurogastrx.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06500429: Completed Phase 2 study of Healthy and Overweight and Obesity, sponsored by Neurogastrx.
NCT06500429 is a Phase 2 study of Healthy and Overweight and Obesity that has completed, run by Neurogastrx. The registered enrollment target is 120 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06500429, a Phase 2 study of Healthy and Overweight and Obesity, has completed, sponsored by Neurogastrx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg twice daily \[BID\]) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a Glucagon-like Peptide-1 (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. Gastrointestinal (GI)-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.
Primary Outcome
Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Semaglutide Injectable Product
- DRUG NG101
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2024-09-13 |
| Phase | Phase 2 |
What the finished NCT06500429 record still lists
NCT06500429 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06500429 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06500429 about?
NCT06500429 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist". Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg twice daily \[BID\]) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a Glucagon-like Peptide-1 (GLP-1) agonist (semagl...
What is the current status of trial NCT06500429?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-06-24. Estimated completion is 2024-09-13.
What conditions does trial NCT06500429 study?
This clinical trial studies the following conditions: Healthy, Overweight and Obesity.
What interventions are being tested in trial NCT06500429?
The interventions under investigation include: Placebo (DRUG), Semaglutide Injectable Product (DRUG), NG101 (DRUG).
Who is sponsoring clinical trial NCT06500429?
This trial is sponsored by Neurogastrx, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06500429 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06500429's enrollment target sits among peer trials
120 182nd of 1090 higher than 896 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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