Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-22 @ 9:00 AM
Study NCT ID:
NCT00537420
Status:
COMPLETED
Last Update Posted:
2008-09-15
First Post:
2007-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061785', 'term': 'peptide YY (3-36)'}, {'id': 'C058254', 'term': 'sibutramine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-12', 'studyFirstSubmitDate': '2007-09-28', 'studyFirstSubmitQcDate': '2007-09-28', 'lastUpdatePostDateStruct': {'date': '2008-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment', 'timeFrame': '24 Weeks'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo', 'timeFrame': '24 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weight loss', 'dieting'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.', 'detailedDescription': 'This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients. The primary objective of the study is to evaluate the effect of increasing nasal PYY3-36 dosing on weight loss post 24 weeks of treatment.\n\nSecondary Objectives:\n\n* To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo\n* To compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal PYY3 36 dose groups versus the nasal placebo group\n* To compare the proportion of patients who lose at least 5% and 10% of the baseline body weight post 12 and 24 weeks of therapy for each of the three nasal PYY3 36 dose groups versus the nasal placebo group\n* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule placebo\n* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule placebo\n* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal PYY3 36 dose groups\n* To evaluate the effect of 12 and 24 weeks of treatment with nasal PYY3 36 and sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse, waist circumference and BMI\n* To evaluate the effect of 24 weeks of treatment with nasal PYY3 36 and sibutramine on HbA1c levels'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients 18 and 65 years, inclusive;\n* BMI 30-43 kg/m2, inclusive;\n* In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;\n* Non-smoker and no use of tobacco or nicotine products for at least 3 months;\n* Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;\n* Has normal nasal mucosa.\n\nExclusion Criteria:\n\n* Previous surgical treatment for obesity;\n* Serious Medical Condition\n* Serious Psychiatric illness\n* Organic causes of obesity (e.g. untreated hypothyroidism)\n* Type 1 or Type 2 Diabetes;\n* Presence of uncontrolled hypertension\n* On prohibited concomitant medication'}, 'identificationModule': {'nctId': 'NCT00537420', 'briefTitle': 'A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nastech Pharmaceutical Company, Inc.'}, 'officialTitle': 'A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients', 'orgStudyIdInfo': {'id': 'C07-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Nasal Placebo', 'interventionNames': ['Drug: Nasal Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Capsule Placebo', 'interventionNames': ['Drug: Placebo Capsule']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Nasal PYY3-36 200 ug', 'interventionNames': ['Drug: PYY3-36']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Nasal PYY3-36 400 ug', 'interventionNames': ['Drug: PYY3-36']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Nasal PYY3-36 600 ug', 'interventionNames': ['Drug: PYY3-36']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6', 'description': 'Sibutramine 10 mg', 'interventionNames': ['Drug: Sibutramine']}], 'interventions': [{'name': 'Nasal Placebo', 'type': 'DRUG', 'description': 'Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.', 'armGroupLabels': ['1']}, {'name': 'Placebo Capsule', 'type': 'DRUG', 'description': 'Placebo capsules will be taken once daily with or without food.', 'armGroupLabels': ['2']}, {'name': 'PYY3-36', 'type': 'DRUG', 'description': 'Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.', 'armGroupLabels': ['3']}, {'name': 'PYY3-36', 'type': 'DRUG', 'description': 'Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.', 'armGroupLabels': ['4']}, {'name': 'PYY3-36', 'type': 'DRUG', 'description': 'Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.', 'armGroupLabels': ['5']}, {'name': 'Sibutramine', 'type': 'DRUG', 'otherNames': ['Meridia'], 'description': 'Sibutramine will be taken once daily with or without food', 'armGroupLabels': ['6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '92869', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '55430', 'city': 'Brooklyn Center', 'state': 'Minnesota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 45.07608, 'lon': -93.33273}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '13104', 'city': 'Manlius', 'state': 'New York', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 43.00201, 'lon': -75.97686}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19606', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}, {'zip': '29651', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78229-3894', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84049', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-425-415-3011', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Gordon Brandt, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nastech Pharmaceutical Company, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nastech Pharmaceutical Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gordon Brandt, M.D. / President', 'oldOrganization': 'Nastech Pharmaceutical Company, Inc.'}}}}