Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01642550|
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Drug: RM-131 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Nervosa|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: RM-131
Active study drug - RM-131
RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
Placebo Comparator: Placebo
- Effect of RM-131 on body weight [ Time Frame: Baseline and Day 28 ]Change from baseline in body weight.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642550
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Anne Klibanski, MD||Massachusetts General Hospital|