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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Neurogastrx, Inc.
Study ID
NCT06500429
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
Sep 2025
Primary completion
Sep 4, 2024
Completion
Sep 13, 2024

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: NG101 20 mg BID
    NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
  • Placebo Comparator: Placebo
    Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide

Primary Outcome Measure

Duration of GI-related adverse events [ Time Frame: 96 hours following GLP-1 agonist injection ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Celerion· Tempe, AZ

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