Study of INT-747 in Patients With Diabetes and Presumed NAFLD
An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
Sponsor: Intercept Pharmaceuticals
A PHASE2 clinical study on Diabetes Mellitus, Type II and Fatty Liver, this trial is completed. The trial is conducted by Intercept Pharmaceuticals and has accumulated 8 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.
Status Flow
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE2
-
Jan 2021 — Dec 2022 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Jul 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Intercept Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .