ObesityPhase 2NCT00993421
A Weight Loss Study in Overweight Men and Women
A Phase 2 study testing LY377604, Sibutramine and Metoprolol in people with Obesity, run by Eli Lilly and Company at 21 sites in United States.
Trial summary
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- LY377604, Sibutramine and Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- 21 sitesUnited States
- Study dates
- Oct 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between the body mass index (BMI) of 27 and 45 kg/m^2, inclusive, at the time of screening.
Who cannot join
- 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).
Show all 22Show fewer
- 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).
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
About this study
Official title: LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.
- Conditions
- Obesity
- Being tested
- LY377604, Sibutramine, Metoprolol, Placebo sibutramine, Placebo Metoprolol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY377604Drug
Given daily, orally for 24 weeks
SibutramineDrug
given daily, orally for 24 weeks
MetoprololDrug
given daily, orally for 24 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), followed by a 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).
Placebo sibutramineDrug
given daily, orally for 24 weeks
Placebo MetoprololDrug
given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)
Placebo LY377604Drug
given daily, orally for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo sibutramine; Drug: Placebo Metoprolol; Drug: Placebo LY377604 |
| LY377604 (75 mg) | Experimental | Not described Receives: Drug: LY377604; Drug: Placebo sibutramine; Drug: Placebo Metoprolol |
| sibutramine (30 mg)/metoprolol (200 mg) | Active comparator | Not described Receives: Drug: Sibutramine; Drug: Metoprolol |
| LY377604 (40 mg)/sibutramine (30 mg) | Experimental | Not described Receives: Drug: LY377604; Drug: Sibutramine; Drug: Placebo Metoprolol |
| LY377604 (75 mg)/sibutramine (30 mg) | Experimental | Not described Receives: Drug: LY377604; Drug: Sibutramine; Drug: Placebo Metoprolol |
| LY377604 (15 mg)/sibutramine (30 mg) | Experimental | Not described Receives: Drug: LY377604; Drug: Sibutramine; Drug: Placebo Metoprolol |
| LY377604 (75 mg)/sibutramine (15 mg) | Experimental | Not described Receives: Drug: LY377604; Drug: Sibutramine; Drug: Placebo Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline to 24 Week Endpoint
Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Secondary outcomes (19)
The Mean Change in Body Weight From Baseline to 24 Week Endpoint
Body weight change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks
Measured: 24 weeks
Change in Heart Rate From Baseline to 24 Week Endpoint
Heart rate change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline heart rate, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Change in Blood Pressure From Baseline to 24 Week Endpoint
Blood pressure change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline blood pressure, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint
Change in body composition (lean body mass and fat mass) was assessed using dual energy x-ray absorptiometry (DXA) and is presented as LSMEAN values with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body composition, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Change in Waist Circumference From Baseline to 24 Week Endpoint
Change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint
Percentage change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.
Measured: Baseline, 24 weeks
Change in Total Cholesterol From Baseline to 24 Weeks Endpoint
Measured: Baseline, 24 weeks
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint
Measured: Baseline, 24 weeks
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint
Measured: Baseline, 24 weeks
Change in Triglycerides From Baseline to 24 Weeks Endpoint
Measured: Baseline, 24 weeks
Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)
Results presented as Least Squares Mean with treatment, visit, and their interaction as fixed effects, subject as random effect, baseline body mass index used as covariate. OWL-QoL consists of 17 items on scale ranging from 0 (Not at all) to 6 (A very great deal). Before calculating scores, each item is reversed. A single quality of life score is computed by summing each item and transforming this raw score onto standardized scale of 0 (greatest impact) to 100 (lowest impact) using formula: score = [(sum of component items score (minus) lowest possible score/ possible raw score range)*100].
Measured: Baseline, 24 weeks
Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale
Vitality change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body mass index was used as covariate. SF-36 is a self-reported questionnaire that consists of 36 questions covering 8 health domains including vitality. The vitality domain results are presented. The vitality domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Measured: Baseline, 24 weeks
Change in Glycated Hemoglobin A1c (HbA1c) From Baseline
Analysis of change in HbA1c was not conducted due to an inadequate number of samples.
Measured: Baseline, 24 weeks
Change in Fasting Glucose From Baseline to 24 Weeks Endpoint
Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.
Measured: Baseline, 24 weeks
Change in Fasting Insulin From Baseline to 24 Weeks Endpoint
Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.
Measured: Baseline, 24 weeks
Change in Insulin Resistance From Baseline to 24 Weeks Endpoint
Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.
Measured: Baseline, 24 weeks
Pharmacokinetics: Area Under the Concentration Time Curve (AUC)
Analysis of AUC was not conducted due to an inadequate number of samples collected.
Measured: 4 weeks, 12 weeks, and 24 weeks
Pharmacokinetics: Maximum Concentration (Cmax)
Analysis of Cmax was not conducted due to an inadequate number of samples collected.
Measured: 4 weeks, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Clinical trial terminated due to results from recent nonclinical studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993421
- Sponsor's protocol ID
- 11892
- Other IDs
- I1L-MC-GAEB
- Status last verified
- Jun 2011
- First submitted
- 9 Oct 2009
- Last updated
- 3 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LY377604 + Sibutramine Hydrochloride Monohydrate: A Phase 2 Weight Loss Efficacy Study in Overweight/Obese Men and Women
- ClinicalTrials.gov ID
- NCT00993421
- Acronym / sponsor ID
- 11892
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical trial terminated due to results from recent nonclinical studies
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Posted 2 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo sibutramine, Drug: Placebo Metoprolol, Drug: Placebo LY377604 |
| LY377604 (75 mg) | Experimental | Drug: LY377604, Drug: Placebo sibutramine, Drug: Placebo Metoprolol |
| sibutramine (30 mg)/metoprolol (200 mg) | Active comparator | Drug: Sibutramine, Drug: Metoprolol |
| LY377604 (40 mg)/sibutramine (30 mg) | Experimental | Drug: LY377604, Drug: Sibutramine, Drug: Placebo Metoprolol |
| LY377604 (75 mg)/sibutramine (30 mg) | Experimental | Drug: LY377604, Drug: Sibutramine, Drug: Placebo Metoprolol |
| LY377604 (15 mg)/sibutramine (30 mg) | Experimental | Drug: LY377604, Drug: Sibutramine, Drug: Placebo Metoprolol |
| LY377604 (75 mg)/sibutramine (15 mg) | Experimental | Drug: LY377604, Drug: Sibutramine, Drug: Placebo Metoprolol |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Are between the body mass index (BMI) of 27 and 45 kg/m^2, inclusive, at the time of screening.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY377604Given daily, orally for 24 weeks | Drug | LY377604 (15 mg)/sibutramine (30 mg), LY377604 (40 mg)/sibutramine (30 mg), LY377604 (75 mg), LY377604 (75 mg)/sibutramine (15 mg), LY377604 (75 mg)/sibutramine (30 mg) |
| Sibutraminegiven daily, orally for 24 weeks | Drug | LY377604 (15 mg)/sibutramine (30 mg), LY377604 (40 mg)/sibutramine (30 mg), LY377604 (75 mg)/sibutramine (15 mg), LY377604 (75 mg)/sibutramine (30 mg), sibutramine (30 mg)/metoprolol (200 mg) |
| Metoprololgiven daily, orally for 24 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), followed by a 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day). | Drug | sibutramine (30 mg)/metoprolol (200 mg) |
| Placebo sibutraminegiven daily, orally for 24 weeks | Drug | LY377604 (75 mg), placebo |
| Placebo Metoprololgiven daily, orally for 26 weeks (24 weeks plus 2 weeks of taper) | Drug | LY377604 (15 mg)/sibutramine (30 mg), LY377604 (40 mg)/sibutramine (30 mg), LY377604 (75 mg), LY377604 (75 mg)/sibutramine (15 mg), LY377604 (75 mg)/sibutramine (30 mg), placebo |
| Placebo LY377604given daily, orally for 24 weeks | Drug | placebo |
Primary outcome
Percent Change in Body Weight From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.
19 secondary outcomes
The Mean Change in Body Weight From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks
Time frame: 24 weeks
Change in Heart Rate From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Change in Blood Pressure From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Change in Waist Circumference From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 weeks
Change in Total Cholesterol From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Change in Triglycerides From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)
Time frame: Baseline, 24 weeks
Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale
Time frame: Baseline, 24 weeks
Change in Glycated Hemoglobin A1c (HbA1c) From Baseline
Time frame: Baseline, 24 weeks
Change in Fasting Glucose From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Change in Fasting Insulin From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Change in Insulin Resistance From Baseline to 24 Weeks Endpoint
Time frame: Baseline, 24 weeks
Pharmacokinetics: Area Under the Concentration Time Curve (AUC)
Time frame: 4 weeks, 12 weeks, and 24 weeks
Pharmacokinetics: Maximum Concentration (Cmax)
Time frame: 4 weeks, 12 weeks, and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Eli Lilly and Company
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY377604, Sibutramine and Metoprolol in people with Obesity, run by Eli Lilly and Company at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight From Baseline to 24 Week Endpoint (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011.