Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients
NCT ID: NCT03205150
Last Updated: 2021-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2017-10-04
2019-11-14
Brief Summary
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Detailed Description
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The study consisted of a 28 day screening period (Day -44 to Day -16), a baseline period of 14 days (Day -15 to Day -1), a treatment period of 12 weeks (Day 1 to Day 84), and a study completion evaluation approximately 28 days after the last drug administration. The patients were advised to maintain their recommended diet during the study.
Patients who met the inclusion/exclusion criteria at screening went to the study site for baseline assessments. All baseline safety evaluation results were available prior to the first dosing.
The study started by enrolling patients into the 150 mg and placebo arms with a randomization ratio of 2:1. After the enrollment of the first 33 patients, the 30 mg arm was added to the study and the randomization ratio changed to a 2:4:1 ratio (150 mg: 30 mg: placebo) to maintain the 2:2:1 ratio across the three groups (150 mg: 30 mg: placebo) at study completion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LIK066 30 mg
Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
LIK066
Film coated tablet of LIK066 either 30mg or 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84
LIK066 150 mg
Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84
LIK066
Film coated tablet of LIK066 either 30mg or 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84
Placebo
LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
Placebo
LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
Interventions
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LIK066
Film coated tablet of LIK066 either 30mg or 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84
Placebo
LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
Eligibility Criteria
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Inclusion Criteria
-Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.
OR
Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:
* ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
* BMI greater than or equal to 27 kg/m\^2 (in patients with a self-identified race other than Asian) or greater than or equal to 23 kg/m\^2 (in patients with a self identified Asian race) AND
* Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%
* Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
* Male and female patients 18 years or older at the time of screening visit.
Exclusion Criteria
* History or current diagnosis of ECG abnormalities
* Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study
* Patients with contraindications to MRI imaging
* Current or history of significant alcohol consumption
* Clinical evidence of hepatic decompensation or severe liver impairment
* Women of child bearing potential (unless on basic contraception methods)
* Presence of liver cirrhosis
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Baton Rouge, Louisiana, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Live Oak, Texas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Haifa, , Israel
Novartis Investigative Site
Ramat Gan, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Chiayi City, , Taiwan
Novartis Investigative Site
Tainan City, , Taiwan
Novartis Investigative Site
Bangkok, , Thailand
Countries
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References
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Harrison SA, Manghi FP, Smith WB, Alpenidze D, Aizenberg D, Klarenbeek N, Chen CY, Zuckerman E, Ravussin E, Charatcharoenwitthaya P, Cheng PN, Katchman H, Klein S, Ben-Ari Z, Mendonza AE, Zhang Y, Martic M, Ma S, Kao S, Tanner S, Pachori A, Badman MK, He Y, Ukomadu C, Sicard E. Licogliflozin for nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a study. Nat Med. 2022 Jul;28(7):1432-1438. doi: 10.1038/s41591-022-01861-9. Epub 2022 Jun 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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2017-002046-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLIK066X2204
Identifier Type: -
Identifier Source: org_study_id
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