Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as pradigastat
LCQ908 · 6 trials · 6 indications
Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.
Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).
The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
This outcome applies to Part I of study involving mild and moderate hepatic impairment as well as healthy volunteers. Blood will be collected on Day 1 (treatment day) within 60 minutes prior to dosing, then, 1,2,4,6,8,10,12 hours after the dosing followed by additional blood draws on Days 2, 3, 4, 5, 6,7, 10, 13, 17, 21 and 28 post dosing.
| Arm | Type | Description |
|---|---|---|
| LCQ908 20 mg | EXPERIMENTAL | In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary. |
| LCQ908 40 mg | EXPERIMENTAL | In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary. |
| Placebo | PLACEBO_COMPARATOR | In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary. |
| pradigastat (LCQ908) 5mg/10mg | EXPERIMENTAL | Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. |
| pradigastat (LCQ908) 10mg/20mg | EXPERIMENTAL | Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study. |
| LCQ908 1 | EXPERIMENTAL | LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks |
| LCQ908 2 | EXPERIMENTAL | LCQ908 once daily for 12 weeks |
| LCQ908 3 | EXPERIMENTAL | LCQ908 once daily for 12 weeks |
| Fenofibrate | ACTIVE_COMPARATOR | Intervention Type: Drug Intervention Name: Fenofibrate |
| Fish Oil | ACTIVE_COMPARATOR | Fish oil once daily for 12 weeks |
| Arm Label: Placebo | PLACEBO_COMPARATOR | Intervention Type: other Intervention Name: other |
| LCQ908 (mild renal impairment plus healthy volunteers) | EXPERIMENTAL | Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with mild renal impairment and will receive a single 40 mg dose of LCQ908. |
| LCQ908 (moderate renal impairment plus healthy volunteers) | EXPERIMENTAL | Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with moderate renal impairment and will receive a single 40 mg dose of LCQ908. |
| LCQ908 (severe renal impairment plus healthy volunteers) | EXPERIMENTAL | Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with severe renal impairment and will receive a single 40 mg dose of LCQ908. |
| LCQ908 (mild hepatic impairment plus healthy volunteers) | EXPERIMENTAL | Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with mild hepatic impairment and will receive a single dose of LCQ908. |
| LCQ908 (moderate hepatic impairment plus healthy volunteers) | EXPERIMENTAL | Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with moderate hepatic impairment and will receive a single dose of LCQ908. |
| LCQ908 (severe hepatic impairment plus healthy volunteers) | EXPERIMENTAL | Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with severe hepatic impairment and will receive a single dose of LCQ908. |
| LCQ908 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LCQ908 | DRUG | LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg |
| Placebo | DRUG | LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg |
| Fenofibrate | DRUG | Fenofibrate once daily 12 weeks |
| Fish Oil | DRUG | Fish Oil once daily for 12 weeks |
| Placebo of LCQ908 | DRUG | Matching placebo of LCQ908 |
| Placebo of fenofibrate | DRUG | Matching placebo of fenofibrate |
| Placebo of fish oil | DRUG | Matching placebo of fish oil capsule |
Key Inclusion Criteria: 1. Written informed consent given before any assessment was performed for Period I. 2. Male and female patients ages at least 18 years of age. 3. Fasting triglyceride ≥ 8.4 mmol/L (750 mg/dL) at Screening. 4. An established diagnosis of FCS (HLP Type I) confirmed through ult...
LCQ908 is an investigational small molecule being developed by Novartis for metabolic conditions including Familial Chylomicronemia Syndrome (FCS), Hepatic Impairment, Non-alcoholic Fatty Liver Disease (NAFLD), Renal Impairment, Non Familial Chylocmicronemia Syndrome (Non-FCS), and Hyperlipoproteinemia. It is in Phase 3 clinical development.
LCQ908 is a small molecule therapeutic being studied for metabolic diseases. Its specific molecular target has not been disclosed in available information. The drug is being evaluated for conditions such as Familial Chylomicronemia Syndrome and Non-alcoholic Fatty Liver Disease.
LCQ908 is developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational small molecule in Phase 3 clinical development for metabolic indications.
LCQ908 is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Clinical trials have been completed for earlier phases, including Phase 1 and Phase 2 studies in various metabolic conditions.
LCQ908 has completed several clinical trials. These include NCT01558323 and NCT01594957, Phase 1 pharmacokinetic studies in patients with renal and hepatic impairment, respectively. NCT01594983 was a Phase 2 pilot study in severe hypertriglyceridemia, and NCT01811472 was a Phase 2 study in NAFLD patients.
LCQ908 is the primary name used in clinical trials and development records. No alternative names have been reported for this investigational drug. It is consistently referred to as LCQ908 across all documented studies.