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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo comparator
RM-131	RM-131	Active study drug - RM-131

Primary Outcome Measures

Name	Time	Method
Effect of RM-131 on body weight	Baseline and Day 28	Change from baseline in body weight.

Secondary Outcome Measures

Name	Time	Method
Effect of RM-131 on appetite	Baseline and Day 28	Change from baseline in appetite.
Effect of RM-131 on gastric emptying time	Baseline and Day 28	Change from baseline in gastric half-emptying time (t1/2).