Study of INT-747 in Patients With Diabetes and Presumed NAFLD

This study has been completed.

Study NCT00501592 Information provided by Intercept Pharmaceuticals

First Received on July 13, 2007. Last Updated on December 21, 2011 History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Diabetes Mellitus, Type II Fatty Liver
Interventions:	Drug: INT-747 Drug: Placebo

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
Sixty four subjects were enrolled in the study at 4 sites. Of the randomized subjects, 20 were randomized to INT-747 25 mg, 21 subjects to INT-747 50 mg, and 23 subjects to placebo. Study enrollment by center ranged from 4 to 31 subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A protocol amendment allowed for the enrollment of 14 replacement subjects (to enroll up to 56 subjects meeting eligibility requirements). The amendment pre-specified that the original 14 subjects being replaced would not be included in the efficacy analysis since they did not meet the protocol requirements.

Reporting Groups

	Description
25 mg INT-747	Once daily by mouth
50 mg INT-747	Once daily by mouth
Placebo	Once daily by mouth

Participant Flow: Overall Study

	25 mg INT-747	50 mg INT-747	Placebo
STARTED	20	21	23
COMPLETED	20	16	20
NOT COMPLETED	0	5	3

Baseline Characteristics

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Reporting Groups

	Description
25 mg INT-747	Once daily by mouth
50 mg INT-747	Once daily by mouth
Placebo	Once daily by mouth

Baseline Measures

	25 mg INT-747	50 mg INT-747	Placebo	Total
Number of Participants [units: participants]	20	21	23	64
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	19	20	20	59
>=65 years	1	1	3	5
Age [units: years] Mean ± Standard Deviation	52.7 ± 8.7	50.5 ± 10.8	53.1 ± 12.1	52.1 ± 10.6
Gender [units: participants]
Female	6	12	13	31
Male	14	9	10	33
Region of Enrollment [units: participants]
United States	20	21	23	64

Outcome Measures

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1. Primary:

Insulin Resistance and Glucose Homeostasis [ Time Frame: baseline and 6 weeks ]

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2. Secondary:

Hepatocellular Function [ Time Frame: baseline and 6 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. Restriction Description: All proposed publications based on this study shall be approved by the Sponsor prior to submission for publication. Such approval will not be unreasonably witheld. Publications will reflect the contributions made by the Investigators, Sponsor personnel and other groups involved in the study.

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: Cathi Sciacca, Sr. Director, Clinical Operations
Organization: Intercept Pharmaceuticals, Inc.
phone: 858-652-6800
e-mail: csciacca@interceptpharma.com

No publications provided

Responsible Party:	Intercept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00501592 History of Changes
Other Study ID Numbers:	747-203
Study First Received:	July 13, 2007
Results First Received:	June 7, 2011
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration