Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT07197034
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D011218', 'term': 'Prader-Willi Syndrome'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score', 'timeFrame': 'During treatment period (approximately 12 months)', 'description': "The HQ-CT score is a 9 question, 5-point scale to describe the PWS patient's hyperphagia food-related problem behaviors. It is completed by the patient's caregiver. Each question is scored from 0 to 4. The minimum total score is 0 (hyperphagia related behavior symptoms not exhibited) and the maximum total score is 36 (hyperphagia related behavior symptoms are observed)."}], 'secondaryOutcomes': [{'measure': 'Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients', 'timeFrame': 'During treatment period (approximately 12 months)', 'description': "The CaGI-S is a single-item, 7-point scale to describe the severity of the PWS patient's hyperphagia (excessive hunger). It is completed by the patient's caregiver. The minimum score is 1 (not present) and the maximum score is 7 (extremely severe). A higher score indicates a worse severity of hyperphagia."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prader-Willi Syndrome', 'ARD-101', 'PWS', 'Prader-Willi', 'Prader Willi', 'Prader Willi Syndrome'], 'conditions': ['Hyperphagia', 'Prader-Willi Syndrome', 'Hyperphagia in Prader-Willi Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us about the safety of ARD-101.\n\nThe main questions it aims to answer are:\n\nWhat medical problems do participants have when taking ARD-101 in a long term setting\n\nDoes ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?\n\nEligible participants will:\n\nHave completed treatment on the AVK-101-301 study through Week 12/End of Treatment\n\nTake ARD-101 every day for up to 12 months.\n\nVisit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101.\n\nPatients/Caregivers will keep a daily diary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who have completed treatment on Aardvark Therapeutics clinical study AVK-101-301\n\nExclusion Criteria:\n\n* Any complications that makes participation unsafe in the Investigator's opinion"}, 'identificationModule': {'nctId': 'NCT07197034', 'briefTitle': 'The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aardvark Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome', 'orgStudyIdInfo': {'id': 'AVK-101-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARD-101', 'description': '(Open-label)', 'interventionNames': ['Drug: ARD-101']}], 'interventions': [{'name': 'ARD-101', 'type': 'DRUG', 'description': '200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks', 'armGroupLabels': ['ARD-101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1711', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hussein Abdul-Latif, MD', 'role': 'CONTACT'}], 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diane Stafford, MD', 'role': 'CONTACT'}], 'facility': "Stanford Children's Health Specialty Services", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lynne Bird, MD', 'role': 'CONTACT'}, {'name': 'Katherine Bunda', 'role': 'CONTACT', 'email': 'kbunda@health.ucsd.edu', 'phone': '858-236-5145'}], 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045-7106', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shawn McCandless, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19803-3607', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Chidekel, MD', 'role': 'CONTACT'}, {'name': 'Kerry Smallacombe, DO', 'role': 'CONTACT', 'email': 'kerry.smallacombe@nemours.org', 'phone': '302-559-0247'}], 'facility': "Nemours Children's Clinic Wilmington", 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32610-3008', 'city': 'Gainesville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Miller, MD', 'role': 'CONTACT'}], 'facility': "UF Shands Children's Hospital", 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30322-1047', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Gambello, MD', 'role': 'CONTACT'}], 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611-2991', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Priya Khanna, MD', 'role': 'CONTACT'}], 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287-0005', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Scheimann, MD', 'role': 'CONTACT'}], 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55102', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bradley Miller, MD', 'role': 'CONTACT'}], 'facility': "University of Minnesota Masonic Children's Hospital", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '11219-2918', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward Yi, MD', 'role': 'CONTACT'}], 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11501-4077', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorge Mejia-Corletto, MD', 'role': 'CONTACT'}], 'facility': "NYU Langone Children's Ambulatory Care Center", 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '37232-0005', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Shoemaker, MD', 'role': 'CONTACT'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sani Roy, MD', 'role': 'CONTACT'}], 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabella Niu, MD', 'role': 'CONTACT'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tania Markovic, MD', 'role': 'CONTACT'}], 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Yoon Hi Cho, MD', 'role': 'CONTACT'}], 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Helen Heussler, MD', 'role': 'CONTACT'}], 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Josephine Ho, MD', 'role': 'CONTACT'}], 'facility': "Alberta Children's Hospital Research Institute", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andrea Haqq, MD', 'role': 'CONTACT'}], 'facility': 'Li Ka Shing Centre for Health Research Innovation', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nathalie Alos, MD', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Universitaire Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '31300', 'city': 'Toulouse', 'state': 'Haute-Garonne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gwenaelle Diene, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Toulouse-Hôpital Des Enfants', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '49933', 'city': 'Angers', 'state': 'Maine-et-Loire', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic Illouz, MD', 'role': 'CONTACT'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '75013', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christine Poitou-Bernert, MD', 'role': 'CONTACT'}], 'facility': 'AP-HP - Hôpital de la Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Graziella Pinto, MD', 'role': 'CONTACT'}], 'facility': 'AP-HP - Hôpital universitaire Necker-Enfants malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Montastier, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Toulouse- Hôpital de Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Danilo Fintini, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Pediatrico Bambino Gesù IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Pajno, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale San Raffaele S.r.l. - PPDS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Stagi, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '41408', 'city': 'Bucharest', 'state': 'București', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Madalina Leanca, MD', 'role': 'CONTACT'}], 'facility': 'National University Hospital for Children\'s Neurorehabilitation "Dr. Nicolae Robanescu"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '11852', 'city': 'Bucharest', 'status': 'NOT_YET_RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Iuliana Gherlan, MD', 'role': 'CONTACT'}], 'facility': 'Institutul National de Endocrinologie C. I. Parhon', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700125', 'city': 'Iași', 'status': 'NOT_YET_RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Cristina Preda, MD', 'role': 'CONTACT'}], 'facility': 'Spitalul Clinic de Urgenta Sfantul Spiridon', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '22332', 'city': 'Incheon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Eun Lee, MD', 'role': 'CONTACT'}], 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '06351', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Yoon Cho, MD', 'role': 'CONTACT'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16499', 'city': 'Suwon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Bae Sohn, MD', 'role': 'CONTACT'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raquel Corripio Collado, MD', 'role': 'CONTACT'}], 'facility': 'Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eduard Mogas Vinals, MD', 'role': 'CONTACT'}], 'facility': "Hospital Universitario Vall d'Hebron - PPDS", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Irene Lazaro Rodriquez, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CB21 5EF', 'city': 'Cambridge', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Shahid Zaman, MD', 'role': 'CONTACT'}], 'facility': 'Fulborn Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mohamad Guftar Shaikh, MBBS', 'role': 'CONTACT'}], 'facility': 'Royal Hospital for Children (Glasgow) - PPDS - PIN', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'James Greening, MD', 'role': 'CONTACT'}], 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'E1 1BB', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Evelien Gevers, MD', 'role': 'CONTACT'}], 'facility': 'The Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Vanessa Wong', 'role': 'CONTACT', 'email': 'Info@AardvarkTherapeutics.com', 'phone': '858-225-7696'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aardvark Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}