phase 2 pilot study to evaluate the safety and efficacy of rm-131 administered to females with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: 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.


Eligibility criteria:
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 \ 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.

Keywords: anorexia nervosa anorexia eating disorders