Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-27 @ 5:50 PM
Study NCT ID:
NCT01642550
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2012-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593860', 'term': 'relamorelin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'dispFirstSubmitDate': '2015-12-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2012-07-13', 'dispFirstSubmitQcDate': '2015-12-02', 'studyFirstSubmitQcDate': '2012-07-16', 'dispFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of RM-131 on body weight', 'timeFrame': 'Baseline and Day 28', 'description': 'Change from baseline in body weight.'}], 'secondaryOutcomes': [{'measure': 'Effect of RM-131 on gastric emptying time', 'timeFrame': 'Baseline and Day 28', 'description': 'Change from baseline in gastric half-emptying time (t1/2).'}, {'measure': 'Effect of RM-131 on appetite', 'timeFrame': 'Baseline and Day 28', 'description': 'Change from baseline in appetite.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia nervosa', 'Anorexia', 'Eating disorders'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '29325236', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV criteria for anorexia nervosa, including weight \\<85% of ideal body weight (IBW) and amenorrhea for three months;\n* Age 18-45 years old;\n* Gastrointestinal tract symptoms;\n* 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);\n* Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to baseline;\n* 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.\n* Patient has a primary care physician or treatment team managing her care.\n\nExclusion Criteria:\n\n* 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;\n* Pregnancy, lactation or breastfeeding, or a positive serum or urine pregnancy test, within eight weeks of screening;\n* History of diabetes mellitus;\n* History of purging behaviors greater than once monthly within the last three months;\n* Active substance abuse;\n* 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\\];\n* 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;\n* Currently receiving parenteral feeding or enteral feeding, or presence of a nasogastric or other enteral tube for feeding or decompression;\n* History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure, small or large bowel resection;\n* Clinical suspicion, in the opinion of the investigator, of active or symptomatic peptic ulcer disease, cholelithiasis, colitis, celiac sprue, or inflammatory bowel disease;\n* Active suicidal ideation;\n* Beck Depression Inventory-2 score of ≥ 29;\n* Current inpatient hospitalization;\n* Allergic or intolerant of egg, milk, wheat or algae, as these are components of the GEBT test meal;\n* Participation in a clinical study with an investigational medication or device within the 30 days prior to dosing in the present study;\n* 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.'}, 'identificationModule': {'nctId': 'NCT01642550', 'briefTitle': 'Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Motus Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RM-131-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RM-131', 'description': 'Active study drug - RM-131', 'interventionNames': ['Drug: RM-131']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RM-131', 'type': 'DRUG', 'description': 'RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.', 'armGroupLabels': ['RM-131']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anne Klibanski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Motus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}