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

NCT01642550 | Completed Phase 2 DMC

• 1 other identifier: RM-131-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; Anorexia; Eating disorders

Outcome Measures

Primary Outcomes (1)

• Effect of RM-131 on body weight

  Change from baseline in body weight.

  Baseline and Day 28

Secondary Outcomes (2)

• Effect of RM-131 on gastric emptying time

  Baseline and Day 28

• Effect of RM-131 on appetite

  Baseline and Day 28

Study Arms (2)

RM-131

ACTIVE COMPARATOR

Active study drug - RM-131

Drug: RM-131

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Interventions

RM-131 DRUG

RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.

RM-131

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Motus Therapeutics, Inc.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Fazeli PK, Lawson EA, Faje AT, Eddy KT, Lee H, Fiedorek FT, Breggia A, Gaal IM, DeSanti R, Klibanski A. Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11585. doi: 10.4088/JCP.17m11585.

  PMID: 29325236 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Anorexia; Feeding and Eating Disorders

Interventions

relamorelin

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Klibanski, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

US (1)