A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2024-09-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight and Obesity Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NG101 20 mg BID

NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide

Group Type EXPERIMENTAL

NG101

Intervention Type DRUG

NG101 20 mg BID

Semaglutide Injectable Product

Intervention Type DRUG

Semaglutide 0.5 or 1 mg

Placebo

Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo BID

Semaglutide Injectable Product

Intervention Type DRUG

Semaglutide 0.5 or 1 mg

Interventions

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NG101

NG101 20 mg BID

Intervention Type DRUG

Placebo

Placebo BID

Intervention Type DRUG

Semaglutide Injectable Product

Semaglutide 0.5 or 1 mg

Intervention Type DRUG

Other Intervention Names

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metopimazine mesylate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes