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 being developed for metabolic conditions, including hypercholesterolemia, severe hypertriglyceridemia, and insulin sensitivity. It is being studied in patients with high cholesterol and related lipid disorders, including those already on statin therapy.
Gemcabene is being developed by MetaVia Inc., a biopharmaceutical company traded on the NASDAQ under the ticker MTVA. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with lipid disorders.
Gemcabene is in Phase 2 clinical development. It has completed multiple Phase 1 and Phase 2 trials, including studies in hypercholesterolemic patients on stable statin therapy and in patients with low HDL-C and elevated triglycerides. It is not yet approved and remains investigational.
Gemcabene has been studied in five completed trials with a total enrollment of 574 participants. Key trials include NCT02571257, a Phase 2 study in hypercholesterolemic patients on statins, and NCT02585869, a Phase 2 study in patients with low HDL-C and elevated triglycerides. Phase 1 trials include NCT02587364 and NCT02587390.
Gemcabene is a distinct investigational compound developed by MetaVia Inc. It is not known to be marketed under any other name. The drug is being evaluated for its effects on cholesterol and triglyceride levels in patients with metabolic disorders.
Gemcabene is being tested in randomized, double-blind, active-controlled trials. These studies compare the drug against an active control to assess its efficacy and safety. The completed trials include both Phase 1 pharmacokinetic studies in healthy volunteers and Phase 2 efficacy studies in patients with hypercholesterolemia.