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ALN-CIDEB · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| ALN-CIDEB Dose Level 1 | EXPERIMENTAL | - |
| ALN-CIDEB Dose Level 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ALN-CIDEB Dose 1 | EXPERIMENTAL | - |
| ALN-CIDEB Dose 2 | EXPERIMENTAL | - |
| Part A | EXPERIMENTAL | Randomized per the protocol |
| Part B | EXPERIMENTAL | Randomized per the protocol |
| Name | Type | Description |
|---|---|---|
| ALN-CIDEB | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Has a clinical diagnosis of MASLD, as defined in the protocol 2. Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol Key Exclusio...
ALN-CIDEB is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. for metabolic liver diseases. It is being studied in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). It has not been approved by the FDA and remains in clinical development.
ALN-CIDEB is being evaluated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including fibrotic MASH, and for metabolic dysfunction-associated steatotic liver disease (MASLD). These are chronic metabolic liver conditions. The drug is investigational, so it is not yet available as a treatment outside of clinical trials.
ALN-CIDEB is being developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating the drug in metabolic liver disease.
ALN-CIDEB is in Phase 2 development overall, with trials spanning Phase 1 through Phase 3. A Phase 3 trial in MASLD and a Phase 2 trial in fibrotic MASH are both listed as not yet recruiting, while a Phase 1 MASLD/MASH study is currently recruiting. The drug is investigational and not FDA approved.
ALN-CIDEB is being studied in three registered trials. NCT06836609 is a recruiting Phase 1 study in MASLD or MASH. NCT07631637 is a Phase 2 study in fibrotic MASH, and NCT07854782 is a Phase 3 study in MASLD. The Phase 2 and Phase 3 trials are not yet recruiting.
The ALN-CIDEB clinical program has a combined planned enrollment of 1,632 participants across its trials. The Phase 3 MASLD study plans to enroll 1,500 adults, the Phase 2 fibrotic MASH study plans 150, and the Phase 1 MASLD/MASH study plans 132. All three are randomized, double-blind, and placebo-controlled.