Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gemcabene · 10 trials · 6 indications
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF).
Cmax
Area Under the Curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Gemcabene 300 mg | EXPERIMENTAL | Participants received 300 mg Gemcabene orally, once daily for 12 weeks. |
| Gemcabene 600 mg | EXPERIMENTAL | Participants received 600 mg Gemcabene orally, once daily for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received matching placebo orally, once daily for 12 weeks. |
| Gemcabene | EXPERIMENTAL | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 milligram (mg) of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. Participants were followed until Day 112. |
| Gemcabene 900 mg | EXPERIMENTAL | Gemcabene 900 mg QD |
| Atorvastatin 10 mg | ACTIVE_COMPARATOR | - |
| Atorvastatin 40 mg | ACTIVE_COMPARATOR | - |
| Atorvastatin 80 mg | ACTIVE_COMPARATOR | - |
| Gemcabene 300 mg & Atorvastatin 10 mg | EXPERIMENTAL | - |
| Gemcabene 300 mg & Atorvastatin 40 mg | EXPERIMENTAL | - |
| Gemcabene 300 mg & Atorvastatin 80 mg | EXPERIMENTAL | - |
| Gemcabene 600 mg & Atorvastatin 10 mg | EXPERIMENTAL | - |
| Gemcabene 600 mg & Atorvastatin 40 mg | EXPERIMENTAL | - |
| Gemcabene 600 mg & Atorvastatin 80 mg | EXPERIMENTAL | - |
| Gemcabene 900 mg & Atorvastatin 10 mg | EXPERIMENTAL | - |
| Gemcabene 900 mg & Atorvastatin 40 mg | EXPERIMENTAL | - |
| Gemcabene 900 mg & Atorvastatin 80 mg | EXPERIMENTAL | - |
| Gemcabene 300 mg QD | EXPERIMENTAL | Gemcabene (also known as CI-1027) treatment on stable background statin therapy |
| Gemcabene 900 mg QD | EXPERIMENTAL | Gemcabene (also known as CI-1027) treatment on stable background statin therapy |
| Gemcabene 150 mg | EXPERIMENTAL | Gemcabene 150 mg once daily (QD) |
| Simvastatin 80 mg | ACTIVE_COMPARATOR | Simvastatin 80 mg |
| Gemcabene 50 mg | EXPERIMENTAL | Gemcabene 50 mg |
| Gemcabene 450 mg | EXPERIMENTAL | Gemcabene 450 mg |
| Gemcabene 750/600 mg | EXPERIMENTAL | Gemcabene 750/600 mg |
| Name | Type | Description |
|---|---|---|
| Gemcabene | DRUG | Gemcabene tablets administered orally once daily, for 12 weeks. |
| Placebo | DRUG | Placebo tablets administered orally once daily, for 12 weeks. |
| Atorvastatin | DRUG | Atorvastatin |
| Gemcabene 900 mg | DRUG | Gemcabene 900 mg once daily (QD) |
| Gemcabene 150 mg | DRUG | Blinded capsules and tablets, 150 mg, once daily, 84 days |
| Gemcabene 300 mg | DRUG | Blinded capsules and tablets, 300 mg, once daily, 84 days |
| Gemcabene 600 mg | DRUG | Blinded capsules and tablets, 600 mg, once daily, 84 days |
| Simvastatin 80 mg | DRUG | 2x40 mg Simvastatin tablets orally once daily (QD) for 15 days |
| Gemcabene 50 mg | DRUG | Gemcabene 50 mg once daily (QD) |
| Gemcabene 450 mg | DRUG | Gemcabene 450 mg once daily (QD) |
| Gemcabene 750/600 mg | DRUG | Gemcabene 750/600 mg once daily (QD) |
Inclusion Criteria: Subjects who meet all of the following criteria will be eligible to participate in the study: 1. Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedure; 2. Male or female (neither pregnant or lactating) ≥18 years of...
Gemcabene is an investigational small molecule developed by MetaVia Inc. (ticker MTVA) for metabolic conditions. It has been studied in hypercholesterolemia, severe hypertriglyceridemia, and insulin sensitivity. It is a Phase 2 candidate and has not been approved by the FDA. Five clinical trials of Gemcabene have been completed, enrolling 574 participants in total.
Gemcabene has been studied for hypercholesterolemia, including homozygous familial hypercholesterolemia, severe hypertriglyceridemia, and insulin sensitivity. Trials evaluated it as monotherapy, in combination with atorvastatin, and in patients on stable moderate and high-intensity statin therapy. It remains investigational and is not approved for any indication.
Gemcabene is being developed by MetaVia Inc., which trades under the ticker MTVA. The company has sponsored Phase 2 clinical studies of the drug in lipid disorders and metabolic conditions. Development has focused on hypercholesterolemia and severe hypertriglyceridemia.
Gemcabene is in Phase 2 development. All five of its clinical trials are Phase 2 studies, and all five are completed, with no trials currently active. The program has enrolled 574 participants across randomized, double-blind, active-controlled studies. Gemcabene is investigational and has not been approved by the FDA.
Gemcabene has been evaluated in five completed Phase 2 trials. These include NCT02944383 in severe hypertriglyceridemia, NCT02722408 (COBALT-1) in homozygous familial hypercholesterolemia, NCT02634151 in hypercholesterolemia patients on statins, and NCT02591836 as monotherapy or with atorvastatin. Enrollment ranged from 8 to 277 participants.