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A Weight Loss Study in Overweight Men and Women
This study is ongoing, but not recruiting participants.
First Received: October 9, 2009   Last Updated: January 8, 2010   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00993421
  Purpose

The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.


Condition Intervention Phase
Obesity
Drug: LY377604
Drug: Sibutramine
Drug: Metoprolol XL
Drug: Placebo sibutramine
Drug: Placebo Metoprolol XL
Drug: Placebo LY377604
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The percent change in body weight from baseline to 24 week endpoint. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean change in body weight from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in Heart Rate from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in Blood Pressure from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in Waist Circumference from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants who achieve a minimum of 10% weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics AUC [ Time Frame: 4 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Percentage change in waist circumference from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in Glycated hemoglobin A1c (HbA1c) from baseline [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline for OWL-QOL [Obesity weight loss quality of life instrument including weight-related symptoms measurement (WRSM)] [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) scale [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in body Composition using Dual Energy X-ray Absorptiometry (DXA) from baseline to 24 week endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in Total cholesterol from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in High-density lipoprotein Cholesterol (HDL-C) from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in Trigylcerides from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting glucose from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting insulin from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in Low-density lipoprotein Cholesterol (LDL-C) from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in insulin resistance from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics Cmax [ Time Frame: 4 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: October 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
placebo: Placebo Comparator Drug: Placebo sibutramine
given orally daily, for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
Drug: Placebo LY377604
given daily, orally for 24 weeks
LY377604 (75mg): Experimental Drug: LY377604
Given daily orally for 24 weeks
Drug: Placebo sibutramine
given orally daily, for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
sibutramine (30mg)/metoprolol XL (200mg): Active Comparator Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Metoprolol XL
given daily, orally for 26 weeks (100 mg for 1 week followed by 200 mg for 23 weeks. Patients unable to tolerate 200 mg will be dose reduced to 100 mg;100 mg at week 25 and 50 mg at week 26)
Drug: Placebo LY377604
given daily, orally for 24 weeks
LY377604 (40mg)/sibutramine (30mg): Experimental Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
LY377604 (75mg)/sibutramine (30mg): Experimental Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
LY377604 (15mg)/sibutramine (30mg): Experimental Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks
LY377604 (75mg)/sibutramine (15mg): Experimental Drug: LY377604
Given daily orally for 24 weeks
Drug: Sibutramine
given daily, orally for 24 weeks
Drug: Placebo Metoprolol XL
given daily,orally for 26 weeks

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are between the body mass index (BMI) of 27 and 45 kg/m2, inclusive, at the time of screening.

Exclusion Criteria:

  • Have a Diastolic Blood Pressure (DBP) greater than 90 mm Hg or less than 55 mm Hg, and/or Systolic Blood Pressure (SBP) >140 mm Hg or <90 mmHg, confirmed by at least 1 repeat measurement. Subjects with hypertension treated with antihypertensive medication are not excluded if blood pressure is within the prescribed limits and they are not treated with excluded medications. Changes in antihypertensive medication are not permitted within 30 days prior to randomization
  • Previous history of poorly controlled hypertension, (that is, >160/100 or hypertension which requires more than 2 drugs for control).
  • Have a pulse rate >90 bpm or <50 bpm.
  • Evidence or history of prior significant cardiovascular disease, coronary artery disease, cardiovascular surgery, significant valvular disease, heart failure, arrhythmias, sick sinus syndrome or stroke.
  • Current treatment with β-blockers, calcium channel blockers, digitalis glycosides (for example, digoxin, etc), or clonidine.
  • Recent treatment (within 2 weeks prior to randomization) with catecholamine-depleting drugs (such as reserpine or tetrabenazine, monoamine oxidase inhibitors (MAOIs).
  • Current treatment with serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRI), any drug that is a serotonin, norepinephrine, or dopamine reuptake inhibitor, "triptan" or ergot therapies for migraine or nausea, or serotonin-releasing agents.
  • Treatment with significant inhibitors of Cytochrome P2D6 (CYP2D6), such as bupropion, fluoxetine, paroxetine, quinidine, duloxetine, amiodarone, cimetidine, chlorpheniramine, clomipramine, doxepin, haloperidol, methadone, mibefradil, and ritonavir.
  • Participants with bronchospastic diseases or who are treated with bronchodilators or other prescription or nonprescription beta adrenergic agonists.
  • Peripheral vascular disease
  • History of thyrotoxicosis
  • History of seizures (except for childhood febrile convulsion) or at increased risk of seizures (for example, history of significant head trauma or intracranial surgery).
  • Have had a significant change in weight, defined as a gain or loss of at least 4 kg (9 lb) in the 90 days prior to randomization
  • Have had bariatric surgery (for example, gastric banding or gastric bypass)
  • Have had liposuction within 90 days prior to randomization
  • Have a disease that affects adipose mass or distribution of energy balance (for example, Cushing's syndrome, uncontrolled hyper- or hypothyroidism).
  • Have taken in the 30 days prior to randomization, a medication, herbal product, or nutritional supplement that affects adipose mass or distribution or energy balance, such as glucocorticoids, antiretrovirals, atypical antipsychotics, lithium, valproic acid, lamotrigine, or other anticonvulsants, mirtazapine, bupropion, phentermine, sibutramine, orlistat, rimonabant, amphetamine, or ephedra-containing supplements. Note: Medications that have small and transient effects on weight or medications that may affect weight independent of adipose mass (for example, estrogens or diuretics), may be continued, but may not be started, stopped, or changed during the course of the study.
  • Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder, or nocturnal eating disorder.
  • Have diabetes mellitus treated with medication, or type 2 diabetes mellitus managed with diet and exercise with HbA1C >7.0%.
  • Symptomatic cholelithiasis in the 90 days prior to randomization.
  • Any lifetime history of suicide attempt.
  • History of major depressive disorder in the last 2 years or any lifetime history of severe psychiatric disorders (for example, schizophrenia or bipolar disorder).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993421

  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 11892, I1L-MC-GAEB
Study First Received: October 9, 2009
Last Updated: January 8, 2010
ClinicalTrials.gov Identifier: NCT00993421     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Overweight
Sibutramine
Body Weight
Signs and Symptoms
Therapeutic Uses
Weight Loss
Body Weight Changes
Appetite Depressants
Adrenergic beta-Antagonists
Nutrition Disorders
Anti-Arrhythmia Agents
Antidepressive Agents
Obesity
Sympatholytics
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Anti-Obesity Agents
Autonomic Agents
Metoprolol succinate
Adrenergic Antagonists
Overnutrition
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010