A Weight Loss Study in Overweight Men and Women

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ClinicalTrials.gov Identifier: NCT00993421

Recruitment Status : Terminated (Clinical trial terminated due to results from recent nonclinical studies)

First Posted : October 12, 2009

Results First Posted : June 2, 2011

Last Update Posted : June 3, 2011

Sponsor:

Information provided by:

Eli Lilly and Company

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, 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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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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

Overall Participants Analyzed
[Units: Participants]

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

275

Male

Race (NIH/OMB)
[Units: Participants]

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

273

More than one race

Unknown or Not Reported

Region of Enrollment
[Units: Participants]

United States

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)

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

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)

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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Limitations and Caveats

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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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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.

Results Point of Contact:

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

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00993421 History of Changes
Other Study ID Numbers:	11892 I1L-MC-GAEB ( Other Identifier: Eli Lilly and Company )
First Submitted:	October 9, 2009
First Posted:	October 12, 2009
Results First Submitted:	May 11, 2011
Results First Posted:	June 2, 2011
Last Update Posted:	June 3, 2011

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