A Weight Loss Study in Overweight Men and Women

This study has been terminated.

(Clinical trial terminated due to results from recent nonclinical studies)

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00993421

First received: October 9, 2009

Last updated: June 2, 2011

Last verified: June 2011

History of Changes

Results First Received: May 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Obesity
Interventions:	Drug: LY377604 Drug: Sibutramine Drug: Metoprolol Drug: Placebo sibutramine Drug: Placebo Metoprolol Drug: Placebo LY377604

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo LY377604: given orally, daily for 24 weeks. Placebo sibutramine: given orally, daily for 24 weeks. Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.
LY377604 (75 mg)	Given orally, daily for 24 weeks.
Sibutramine (30 mg)/Metoprolol (200 mg)	sibutramine (30 mg): Given orally, daily for 24 weeks. metoprolol (200 mg): Given orally, daily 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 LY377604: given orally, daily for 24 weeks.
LY377604 (15 mg)/Sibutramine (30 mg)	LY377604 (15 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks.
LY377604 (40 mg)/Sibutramine (30 mg)	LY377604 (40 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.
LY377604 (75 mg)/Sibutramine (30 mg)	LY377604 (75 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.
LY377604 (75 mg)/Sibutramine (15 mg)	LY377604 (75 mg): Given orally, daily for 24 weeks. sibutramine (15 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.

Participant Flow: Overall Study

	Placebo	LY377604 (75 mg)	Sibutramine (30 mg)/Metoprolol (200 mg)	LY377604 (15 mg)/Sibutramine (30 mg)	LY377604 (40 mg)/Sibutramine (30 mg)	LY377604 (75 mg)/Sibutramine (30 mg)	LY377604 (75 mg)/Sibutramine (15 mg)
STARTED	49	49	48	49	52	50	46
COMPLETED	5	4	5	4	6	4	4
NOT COMPLETED	44	45	43	45	46	46	42
Adverse Event	2	7	6	9	5	7	1
Sponsor Decision	36	31	28	30	38	30	29
Lost to Follow-up	3	5	5	0	0	0	6
Withdrawal by Subject	3	2	3	3	3	5	3
Death	0	0	0	0	0	0	1
Entry Criteria Exclusion	0	0	1	3	0	1	0
Physician Decision	0	0	0	0	0	1	1
Protocol Violation	0	0	0	0	0	2	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo LY377604: given orally, daily for 24 weeks. Placebo sibutramine: given orally, daily for 24 weeks. Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper.
LY377604 (75 mg)	Given orally, daily for 24 weeks.
Sibutramine (30 mg)/Metoprolol (200 mg)	sibutramine (30 mg): Given orally, daily for 24 weeks. metoprolol (200 mg): Given orally, daily 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 LY377604: given orally, daily for 24 weeks.
LY377604 (15 mg)/Sibutramine (30 mg)	LY377604 (15 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks.
LY377604 (40 mg)/Sibutramine (30 mg)	LY377604 (40 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.
LY377604 (75 mg)/Sibutramine (30 mg)	LY377604 (75 mg): Given orally, daily for 24 weeks. sibutramine (30 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.
LY377604 (75 mg)/Sibutramine (15 mg)	LY377604 (75 mg): Given orally, daily for 24 weeks. sibutramine (15 mg): Given orally, daily for 24 weeks. Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper.
Total	Total of all reporting groups

Baseline Measures

	Placebo	LY377604 (75 mg)	Sibutramine (30 mg)/Metoprolol (200 mg)	LY377604 (15 mg)/Sibutramine (30 mg)	LY377604 (40 mg)/Sibutramine (30 mg)	LY377604 (75 mg)/Sibutramine (30 mg)	LY377604 (75 mg)/Sibutramine (15 mg)	Total
Number of Participants [units: participants]	49	49	48	49	52	50	46	343
Age [units: years] Mean ± Standard Deviation	42.71 ± 10.86	43.89 ± 11.02	44.68 ± 12.00	43.42 ± 11.06	44.15 ± 10.71	45.80 ± 9.15	43.93 ± 10.15	44.09 ± 10.68
Gender [units: participants]
Female	41	42	38	39	40	41	34	275
Male	8	7	10	10	12	9	12	68
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	1	0	1	0	2
Asian	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	1	0	0	1	2
Black or African American	12	5	8	10	8	6	7	56
White	36	43	39	34	43	42	36	273
More than one race	1	1	1	3	1	1	2	10
Unknown or Not Reported	0	0	0	0	0	0	0	0
Region of Enrollment [units: participants]
United States	49	49	48	49	52	50	46	343
Height [units: centimeters (cm)] Mean ± Standard Deviation	166.10 ± 8.02	166.86 ± 8.40	167.51 ± 9.22	165.23 ± 8.93	168.13 ± 7.88	168.99 ± 8.18	168.38 ± 7.50	167.32 ± 8.34
Weight [units: kilograms (kg)] Mean ± Standard Deviation	97.92 ± 18.73	97.15 ± 15.67	102.25 ± 17.80	96.36 ± 18.08	99.09 ± 17.73	100.96 ± 17.20	100.09 ± 17.11	99.10 ± 17.46
Body Mass Index (BMI) ^[1] [units: kilograms/square meters (kg/m^2)] Mean ± Standard Deviation	35.22 ± 4.96	34.78 ± 4.53	36.34 ± 5.36	35.12 ± 4.55	34.86 ± 4.39	35.30 ± 4.44	35.22 ± 4.87	35.26 ± 4.71
Blood Pressure [units: mm Hg] Mean ± Standard Deviation
Systolic Blood Pressure (SBP)	117.11 ± 11.53	115.72 ± 10.78	117.35 ± 10.13	118.67 ± 11.11	118.34 ± 11.37	119.86 ± 11.42	120.72 ± 11.36	118.24 ± 11.13
Diastolic Blood Pressure (DBP)	75.12 ± 7.31	74.40 ± 7.70	75.83 ± 6.76	76.61 ± 7.07	76.94 ± 6.31	77.87 ± 6.82	78.38 ± 6.23	76.44 ± 6.97
Waist and Hip Circumference [units: centimeters (cm)] Mean ± Standard Deviation
Waist Circumference	109.13 ± 14.10	107.42 ± 10.70	111.47 ± 12.58	107.31 ± 12.06	110.18 ± 10.80	109.99 ± 11.49	109.15 ± 12.95	109.24 ± 12.10
Hip Circumference	119.76 ± 12.36	118.55 ± 9.42	120.29 ± 11.51	117.65 ± 11.13	117.30 ± 14.96	119.43 ± 11.45	118.01 ± 11.43	118.70 ± 11.83

[1]	Body mass index is an estimate of body fat based on body weight (kilograms) divided by height (meters) squared.

Outcome Measures

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1. Primary:

Percent Change in Body Weight From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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2. Secondary:

The Mean Change in Body Weight From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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3. Secondary:

Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks [ Time Frame: 24 weeks ]

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4. Secondary:

Change in Heart Rate From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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5. Secondary:

Change in Blood Pressure From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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6. Secondary:

Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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7. Secondary:

Change in Waist Circumference From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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8. Secondary:

Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]

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9. Secondary:

Change in Total Cholesterol From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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10. Secondary:

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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11. Secondary:

Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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12. Secondary:

Change in Triglycerides From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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13. Secondary:

Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL) [ Time Frame: Baseline, 24 weeks ]

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14. Secondary:

Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale [ Time Frame: Baseline, 24 weeks ]

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15. Secondary:

Change in Glycated Hemoglobin A1c (HbA1c) From Baseline [ Time Frame: Baseline, 24 weeks ]

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16. Secondary:

Change in Fasting Glucose From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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17. Secondary:

Change in Fasting Insulin From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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18. Secondary:

Change in Insulin Resistance From Baseline to 24 Weeks Endpoint [ Time Frame: Baseline, 24 weeks ]

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19. Secondary:

Pharmacokinetics: Area Under the Concentration Time Curve (AUC) [ Time Frame: 4 weeks, 12 weeks, and 24 weeks ]

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20. Secondary:

Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: 4 weeks, 12 weeks, and 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00993421 History of Changes
Other Study ID Numbers:	11892, I1L-MC-GAEB
Study First Received:	October 9, 2009
Results First Received:	May 11, 2011
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration

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