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

Neurogastrx

Status and phase: Active, not recruiting; Phase 2

Conditions: Healthy; Overweight and Obesity

Treatments: Drug: Semaglutide Injectable Product; Drug: Placebo; Drug: NG101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06500429

NG101-202

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

NG101 20 mg BID

Experimental group

Description:

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

Treatment:

Drug: NG101

Drug: Semaglutide Injectable Product

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Semaglutide Injectable Product