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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: RM-131
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV criteria for anorexia nervosa, including weight <85% of ideal body weight (IBW) and amenorrhea for three months; Age 18-45 years old; Gastrointestinal tract symptoms; Non-hormonal method of birth control, which must be used throughout the study. Female patients unable to bear children must have this documented (i.e., tubal ligation, hysterectomy, or post-menopausal, defined as a minimum of one year since the last menstrual period and elevated FSH); Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline; Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures, including daily SC injections and completion of a daily injection log. Patient has a primary care physician or treatment team managing her care. Exclusion Criteria: Use of hormone therapy (including but not limited to estrogen, progesterone) or hormonal methods of birth control (i.e., oral, implantable, or injectable) within eight weeks of screening; or Depo-Provera within six months of screening; Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening; History of diabetes mellitus; History of purging behaviors greater than once monthly within the last three months; Active substance abuse; Use of metoclopramide, erythromycin, 5HT3 anti-emetics, or opioid medications within 2 weeks prior to baseline. [Note: these drugs should also not be used post-baseline]; Hematocrit < 30.0 %, hemoglobin < 10.0 g/dl, potassium < 3.0 mmol/L, fasting glucose > 100 mg/dL, creatinine > 1.5 mg/dL, AST or ALT > 1.5 times the upper limit of normal, or abnormal plasma thyroid stimulating hormone (TSH) level; Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression; History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection; Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease; Active suicidal ideation; Beck Depression Inventory-2 score of ≥ 29; Current inpatient hospitalization; Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal; Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study; Any other reason, which in the opinion of the Investigator, including severe renal, hepatic or cardiac disease, would confound proper interpretation of the study or expose a patient to unacceptable risk.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RM-131<br>Active study drug - RM-131 | Drug: RM-131<br>* RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.<br>|
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of RM-131 on body weight | Change from baseline in body weight. | Baseline and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of RM-131 on gastric emptying time | Change from baseline in gastric half-emptying time (t1/2). | Baseline and Day 28 | 
| Effect of RM-131 on appetite | Change from baseline in appetite. | Baseline and Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia nervosa, Anorexia, Eating disorders