Clinical Trial: Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia

Brief Summary: The purpose of this study is to determine if administration of RM-131 is effective in improving appetite and gastrointestinal symptoms leading to the recovery of patients with anorexia nervosa in the outpatient setting.

Detailed Summary:
Sponsor: Motus Therapeutics, Inc.

Current Primary Outcome: Effect of RM-131 on body weight [ Time Frame: Baseline and Day 28 ]

Change from baseline in body weight.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effect of RM-131 on gastric emptying time [ Time Frame: Baseline and Day 28 ]
    Change from baseline in gastric half-emptying time (t1/2).
  • Effect of RM-131 on appetite [ Time Frame: Baseline and Day 28 ]
    Change from baseline in appetite.


Original Secondary Outcome: Same as current

Information By: Motus Therapeutics, Inc.

Dates:
Date Received: July 13, 2012
Date Started: November 2012
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016