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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|