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A Weight Loss Study in Overweight Men and Women

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: LY377604 (Drug); Sibutramine (Drug); Metoprolol (Drug); Placebo sibutramine (Drug); Placebo Metoprolol (Drug); Placebo LY377604 (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

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

Clinical Details

Official title: LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change in Body Weight From Baseline to 24 Week Endpoint

Secondary outcome:

The Mean Change in Body Weight From Baseline to 24 Week Endpoint

Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks

Change in Heart Rate From Baseline to 24 Week Endpoint

Change in Blood Pressure From Baseline to 24 Week Endpoint

Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint

Change in Waist Circumference From Baseline to 24 Week Endpoint

Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint

Change in Total Cholesterol From Baseline to 24 Weeks Endpoint

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint

Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint

Change in Triglycerides From Baseline to 24 Weeks Endpoint

Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)

Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale

Change in Glycated Hemoglobin A1c (HbA1c) From Baseline

Change in Fasting Glucose From Baseline to 24 Weeks Endpoint

Change in Fasting Insulin From Baseline to 24 Weeks Endpoint

Change in Insulin Resistance From Baseline to 24 Weeks Endpoint

Pharmacokinetics: Area Under the Concentration Time Curve (AUC)

Pharmacokinetics: Maximum Concentration (Cmax)

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Are between the body mass index (BMI) of 27 and 45 kg/m^2, 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 hemoglobin A1c (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).

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mesa, Arizona 85201, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Concord, California 94520, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., La Jolla, California 92037, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Waterbury, Connecticut 06708, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., South Miami, Florida 33143, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Idaho Falls, Idaho 83404, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Avon, Indiana 46123, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bloomington, Indiana 47403, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Carmel, Indiana 46032, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Indianapolis, Indiana 46260, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Des Moines, Iowa 50314, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Topeka, Kansas 66606, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Baton Rouge, Louisiana 70808, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Haverhill, Massachusetts 01830, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sterling Heights, Michigan 48314, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Minneapolis, Minnesota 55416, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Las Vegas, Nevada 89130, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wilmington, North Carolina 28401, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Portland, Oregon 97210, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dallas, Texas 75230, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Richmond, Virginia 23233, United States

Additional Information

Starting date: October 2009
Last updated: June 2, 2011

Page last updated: August 23, 2015

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