Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-29 @ 9:58 PM
Study NCT ID:
NCT00394667
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2006-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tesofensine on Weight Reduction in Patients With Obesity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518479', 'term': 'Tesofensine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-19', 'studyFirstSubmitDate': '2006-10-31', 'studyFirstSubmitQcDate': '2006-10-31', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change and absolute change in body weight'}], 'secondaryOutcomes': [{'measure': 'Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA'}, {'measure': 'blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin )'}, {'measure': 'data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite))'}, {'measure': 'Safety & Tolerability'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23561987', 'type': 'BACKGROUND', 'citation': 'Expression of concern--effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Apr 6;381(9873):1167. doi: 10.1016/S0140-6736(13)60778-3. No abstract available.'}, {'pmid': '21720440', 'type': 'DERIVED', 'citation': 'Gilbert JA, Gasteyger C, Raben A, Meier DH, Astrup A, Sjodin A. The effect of tesofensine on appetite sensations. Obesity (Silver Spring). 2012 Mar;20(3):553-61. doi: 10.1038/oby.2011.197. Epub 2011 Jun 30.'}, {'pmid': '18950853', 'type': 'DERIVED', 'citation': 'Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Nov 29;372(9653):1906-1913. doi: 10.1016/S0140-6736(08)61525-1. Epub 2008 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Obese patients with 30 kg/m² ≤ BMI ≤ 40 kg/m²\n* Males and females 18 to 65 years of age, extremes included\n* Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomization do not gain weight (\\< 2 kg)\n* Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD or surgically sterilized)\n* Patients should be able to comply with study procedures\n* Smoking habits should have been stable for at least 2 months\n* Patients giving written informed consent\n\nExclusion Criteria:\n\n* Use of prescription medication as listed\n* Positive serum pregnancy test for women of childbearing potential\n* Pregnant or lactating women, or women who are planning to become pregnant within the next 8 months\n* Patients with specific diseases interfering with their metabolism e.g. untreated myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.\n* Patients with Type 2 diabetes mellitus are ineligible unless anti-diabetic medication was not deemed necessary by the investigator and fasting (venous or arterialized capillary full blood from finger or ear) blood glucose \\> 6.1 mmol/l at screening. Re-test is allowed if first measure is above inclusion value. The corresponding exclusion criteria for plasma glucose is 7.0 mmol/l\n* Patients currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption \\> 21 units of alcohol (men) or \\>14 units of alcohol (women))\n* Hepatic or renal dysfunction (ASAT and/or ALAT \\> 2 x ULN and creatinine clearance \\< 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively)\n* Known untreated hypercholesterolaemia (\\> 7 mmol/l). Patients with well regulated cholesterol using drugs for hypercholesterolaemia are allowed inclusion\n* Known untreated hypertriglyceridaemia (\\> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion\n* Drug treated thyroid diseases (well substituted hypothyroidism is allowed)\n* Patients who suffer from hyperthyroid disease are not allowed in the study, even though they may be well treated by drugs\n* Patients, who have recently diagnosed, not yet stable hypothyroid disease are not allowed in the study\n* Patients who suffer from longstanding stable hypothyroid disease, well treated substitution are allowed to be included including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine\n* Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine\n* Special diets (e.g., vegetarian, Atkins)\n* Patients planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator\n* Weight change of \\> 3 kg within 2 months prior to screening\n* Mental or psychiatric disorder based on medical history only\n* Surgically treated obesity\n* Patients with systemic infections or inflammatory diseases\n* History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks\n* Significant abnormalities on the ECG. according to the investigators opinion. Additional exclusionary ECG values: QTcB \\> 480 milliseconds (ms), PR interval \\> 240 ms, QRS interval \\> 120 ms\n* Hypotension (i.e. supine systolic BP \\< 90 mm Hg) and/or symptomatic orthostatic hypotension (clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mm Hg in systolic BP at one minute after standing compared with the previous supine systolic BP obtained after 5 minutes of quiet rest) at screening visit\n* Uncontrolled hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) despite treatment for \\> 4 weeks prior to the screening visit as well as HR\\>90 bpm\n* Known HIV infection (no tests required)\n* Serologic evidence of active hepatitis B and/or C\n* History of cancer within the past 5 years, excluding treated basal cell carcinoma\n* Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma\n* Current treatment with medication with known ocular toxicity such as chloroquine and hydroxychloroquine is prohibited\n* Patients previously treated with tesofensine\n* Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug"}, 'identificationModule': {'nctId': 'NCT00394667', 'briefTitle': 'Effect of Tesofensine on Weight Reduction in Patients With Obesity.', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroSearch A/S'}, 'officialTitle': 'Effect of Tesofensine on Weight Reduction in Patients With Obesity. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study.', 'orgStudyIdInfo': {'id': 'TIPO-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tesofensine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2750', 'city': 'Ballerup Municipality', 'country': 'Denmark', 'facility': 'NeuroSearch A/S', 'geoPoint': {'lat': 55.73165, 'lon': 12.36328}}], 'overallOfficials': [{'name': 'Arne V Astrup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Nutrition, The Royal Veterinary & Agricultural University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroSearch A/S', 'class': 'INDUSTRY'}}}}