Overweight and ObesityPhase 2NCT06500429
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 testing NG101 and Semaglutide Injectable Product in people with Overweight and Obesity and Healthy, run by Neurogastrx, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Healthy
- What is being tested?
- NG101 and Semaglutide Injectable Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 13 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult
- Male or female
- BMI between 22 - 35 kg/m2 at screening
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-Concept, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Oral NG101 in the Treatment of Side Effects in Healthy Adult Participants Administered a Single Subcutaneous Dose of a Glucagon-Like Peptide 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 (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.
- Conditions
- Overweight and Obesity, Healthy
- Being tested
- NG101, Placebo, Semaglutide Injectable Product
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG101Drug
Also called metopimazine mesylate
NG101 20 mg BID
PlaceboDrug
Placebo BID
Semaglutide Injectable ProductDrug
Semaglutide 0.5 or 1 mg
| Study group | Role | What they receive |
|---|---|---|
| NG101 20 mg BID | Experimental | NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide Receives: Drug: NG101; Drug: Semaglutide Injectable Product |
| Placebo | Placebo comparator | Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide Receives: Drug: Placebo; Drug: Semaglutide Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of GI-related adverse events
Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection
Measured: 96 hours following GLP-1 agonist injection
Severity of GI-related adverse events
Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection
Measured: 96 hours following GLP-1 agonist injection
Secondary outcomes (1)
Number of TEAEs of GI-related adverse events
Number of TEAEs of GI-related adverse events following GLP-1 agonist injection
Measured: 96 hours following GLP-1 agonist injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start24 Jun 2024
- Primary completion4 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurogastrx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500429
- Sponsor's protocol ID
- NG101-202
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Oral NG101 in the Treatment of Side Effects in Healthy Adult Participants Administered a Single Subcutaneous Dose of a Glucagon-Like Peptide 1 Agonist
- ClinicalTrials.gov ID
- NCT06500429
- Acronym / sponsor ID
- NG101-202
- Conditions
- Overweight and Obesity, Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Neurogastrx, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NG101 20 mg BID | Experimental | Drug: NG101, Drug: Semaglutide Injectable ProductNG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Semaglutide Injectable ProductPlacebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult
- Male or female
- BMI between 22 - 35 kg/m2 at screening
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NG101Also: metopimazine mesylateNG101 20 mg BID | Drug | NG101 20 mg BID |
| PlaceboPlacebo BID | Drug | Placebo |
| Semaglutide Injectable ProductSemaglutide 0.5 or 1 mg | Drug | NG101 20 mg BID, Placebo |
Primary outcome
Duration of GI-related adverse events
Time frame: 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
Time frame: 96 hours following GLP-1 agonist injection
Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection
1 secondary outcome
Number of TEAEs of GI-related adverse events
Time frame: 96 hours following GLP-1 agonist injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NG101 and Semaglutide Injectable Product in people with Overweight and Obesity and Healthy, run by Neurogastrx, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of GI-related adverse events (time frame: 96 hours following GLP-1 agonist injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.