Obesity MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Trade Name: Nivalin (galantamine) 5 mg tablets
(in combination with Sertraline (sertraline), see PR2)
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of admi
Sponsors
Theracos, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 30 and = 60 years old 2. Body mass index (BMI) is = 30 kg/m2 and = 40 kg/m2 3. Completed at least 80% of the 7-day diet diary 4. Women of childbearing potential with a negative pregnancy test prior to study entry and who agree to use an acceptable method of contraception throughout the study. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 with absence of menses for at least 12 months. In those subjects = 45 years an elevated serum FSH and the absence of menses for at least 12 months is required. 5. Able to read and give written informed consent and have signed a consent form approved by the Investigator's Institutional Review Board (IRB) or Ethics Committee (EC) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating 2. Allergy to galantamine or sertraline or to any of the excipients 3. Have lost more than 3 kg in the 3 months prior to the screening visit 4. Current or previous use (within 3 months of randomization) of medications that influence weight 5. Current or previous use (within 14 days of randomization) with a MAOI (e.g., phenelzine, tranylcypromine), pimozide or cholinesterase inhibitor drugs (e.g., donezepil, rivastigmine, tacrine), or SSRI drugs (e.g., citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline) or SNRI drugs (e.g., duloxetine, venlafaxine, buproprion), or tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline), or ergot drugs (e.g., ergotamine, dihydroergotamine, caffeine/ergotamine combinations, other combination drugs containing ergotamine) or triptans (e.g., sumatriptan, naratriptan, rizatriptan, almotriptan, zolmitriptan, eletriptan, frovatriptan) 6. Current use of cimetidine, ketoconazole, warfarin 7. Current history of atherosclerosis including cardiovascular disease (myorardial infarction, coronary artery bypass grafting, intracoronary stenting, percutaneous transluminal angioplasty or angina pectoris), peripheral vascular disease and cerebrovascular disease (including transient ischemic attack) 8. Current acute or chronic liver disease, including acute hepatitis, chronic hepatitis, or cirrhosis; elevated total bilirubin > 1.5X ULN, elevated transaminases ALT and AST > 2X ULN or elevated GGT, or elevated alkaline phosphatase 2.5 x ULN 9. Known endocrine origin for the subject's obesity, such as hypothyroidism and Cushing's syndrome 10. Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse 11. Current serious/unstable medical condition including uncontrolled hypertension, active disease of the central nervous system such as seizure disorder, psychiatric illness (including major depression) or uncontrolled infection 12. Current or history of abnormality of cardiac conduction, including first and second degree heart block 13. History of mania/hypomania; history of suicide attempts or suicidal ideation or score indicative of major depression on a depression inventory test 14. "Major" surgery in last 30 days or planned in next 6 months 15. Current pharmacologically treated diabetes or fasting plasma glucose = 126 mg/dL 16. Current active peptic ulcer disease or urinary outflow obstructive disorder and subjects at risk for urinary outflow obstruction such as those with clinecally significant benign prostatic hypertrophy or atonic bladder 17. Current asthma or chronic obstructive pulmonary disease 18. Current or history of renal disease or serum creatinine = 1.5 mg/dl 19. Current or history (within the past year) of alcohol, drug or other substance abuse 20. Participation in another experimental drug or device treatment protocol within the 30 days prior to screening or are scheduled to receive such a drug during the study period 21. Subjects who are not willing or able to fully comply with the protocol 22. Subjects whom the investigator believes to be medically unfit to receive the study treatment, or unsuitable for any other reason 23. Subjects who have previously entered this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the percent change from baseline weight in obese subjects treated with galantamine + sertraline, compared to galantamine, sertraline, and placebo.;Secondary Objective: The secondary efficacy objectives of this study are to compare the proportions of galantamine + sertraline, galantamine, sertraline, and placebo treated obese subjects who achieve weight loss of at least 5% and at least 10%, or more of baseline body weight and to determine the effect of galantamine + sertraline, galantamine, and sertraline on serum lipids, waist circumferences, fasting plasma glucose, and blood pressure.;Primary end point(s): Primary Safety Endpoint: To determine the safety and tolerability of galantamine + sertraline and its individual active component drugs, galantamine and sertraline, in obese subjects as measured by adverse events, physical examination and laboratory tests. Primary Efficacy Endpoint: The percent change from baseline weight in subjects treated with galantamine + sertraline compared to galantamine, sertraline or placebo | — |
Countries
Sweden
Outcome results
None listed