A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist

Phase 2

Active, not recruiting

• Conditions: Overweight and Obesity; Healthy
• Interventions: Drug: NG101; Drug: Placebo; Drug: Semaglutide Injectable Product

• Registration Number: NCT06500429
• Lead Sponsor: Neurogastrx, Inc.

Brief Summary

Adult participants with BMI between 22 - 35 kg/m2 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2024-09-18
• Study Completion: 2024-10-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Healthy adult
• Male or female
• BMI between 22 - 35 kg/m2 at screening

Exclusion Criteria

• Presence or history of illness that might confound the results of the study or pose an -
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NG101 20 mg BID	NG101	NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
NG101 20 mg BID	Semaglutide Injectable Product	NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
Placebo	Placebo	Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide
Placebo	Semaglutide Injectable Product	Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide

Primary Outcome Measures

Name	Time	Method
Duration of GI-related adverse events	96 hours following GLP-1 agonist injection	Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection
Severity of GI-related adverse events	96 hours following GLP-1 agonist injection	Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection

Secondary Outcome Measures

Name	Time	Method
Number of TEAEs of GI-related adverse events	96 hours following GLP-1 agonist injection	Number of TEAEs of GI-related adverse events following GLP-1 agonist injection

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States