Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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.
Baseline, 24 weeks

Secondary Outcomes (19)

The Mean Change in Body Weight From Baseline to 24 Week Endpoint
Baseline, 24 weeks
Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks
24 weeks
Change in Heart Rate From Baseline to 24 Week Endpoint
Baseline, 24 weeks
Change in Blood Pressure From Baseline to 24 Week Endpoint
Baseline, 24 weeks
Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint
Baseline, 24 weeks
+14 more secondary outcomes

Study Arms (7)

placebo

PLACEBO COMPARATOR

Drug: Placebo sibutramineDrug: Placebo MetoprololDrug: Placebo LY377604

LY377604 (75 mg)

EXPERIMENTAL

Drug: LY377604Drug: Placebo sibutramineDrug: Placebo Metoprolol

sibutramine (30 mg)/metoprolol (200 mg)

ACTIVE COMPARATOR

Drug: SibutramineDrug: Metoprolol

LY377604 (40 mg)/sibutramine (30 mg)

EXPERIMENTAL

Drug: LY377604Drug: SibutramineDrug: Placebo Metoprolol

LY377604 (75 mg)/sibutramine (30 mg)

EXPERIMENTAL

Drug: LY377604Drug: SibutramineDrug: Placebo Metoprolol

LY377604 (15 mg)/sibutramine (30 mg)

EXPERIMENTAL

Drug: LY377604Drug: SibutramineDrug: Placebo Metoprolol

LY377604 (75 mg)/sibutramine (15 mg)

EXPERIMENTAL

Drug: LY377604Drug: SibutramineDrug: Placebo Metoprolol

Interventions

LY377604DRUG

Given daily, orally for 24 weeks

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)

SibutramineDRUG

given daily, orally for 24 weeks

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)

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).

sibutramine (30 mg)/metoprolol (200 mg)

Placebo sibutramineDRUG

given daily, orally for 24 weeks

LY377604 (75 mg)placebo

Placebo MetoprololDRUG

given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper)

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 LY377604DRUG

given daily, orally for 24 weeks

placebo

Eligibility Criteria

Age21 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Are between the body mass index (BMI) of 27 and 45 kg/m\^2, inclusive, at the time of screening.

You may not qualify if:

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
+7 more criteria

Contact the study team to confirm eligibility.