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

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.