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NCT01571297 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis

A Phase 2 study, sponsored by Motus Therapeutics.

Completed
Registry status
Phase 2
Development phase
204
Enrollment target

NCT01571297: Completed Phase 2 study, sponsored by Motus Therapeutics.

NCT01571297 is a Phase 2 study that has completed, run by Motus Therapeutics. The registered enrollment target is 204 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01571297, a Phase 2 study, has completed, sponsored by Motus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
204 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the effects of RM-131 on gastric emptying, gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to evaluate the efficacy and safety of multiple dose regimens of RM-131. Study drug (RM-131 and placebo) will be administered subcutaneously in a blinded fashion.

Primary Outcome

Change from baseline in gastric half-emptying time (t½)

Interventions

  • DRUG Placebo
  • DRUG RM-131

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2012-04
Est. Completion 2013-09
Phase Phase 2
Motus Therapeutics

7 total trials

What the finished NCT01571297 record still lists

NCT01571297 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01571297 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01571297 about?

NCT01571297 is a clinical study titled "Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis". The purpose of this study is to evaluate the effects of RM-131 on gastric emptying, gastroparesis symptoms, and the safety and tolerability of RM-131 compared to placebo in patients with Type 1 and Type 2 diabetes mellitus and gastroparesis. The study is designed to evaluate the efficacy and safety ...

What is the current status of trial NCT01571297?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2012-04. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01571297?

The interventions under investigation include: Placebo (DRUG), RM-131 (DRUG).

Who is sponsoring clinical trial NCT01571297?

This trial is sponsored by Motus Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01571297's enrollment target sits among peer trials

204 299th of 2000 higher than 1,700 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01571297, the US trial registry maintained by the National Library of Medicine. NCT01571297 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.