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ALN-PNP · 3 trials · 5 indications
Part A
| Arm | Type | Description |
|---|---|---|
| Part A: A1 | EXPERIMENTAL | - |
| Part A: A2 | EXPERIMENTAL | - |
| Part B: B1 | EXPERIMENTAL | - |
| Part B: B2 | EXPERIMENTAL | - |
| Part B: B3 | EXPERIMENTAL | - |
| Part B: B4 | PLACEBO_COMPARATOR | - |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part A: Low Dose | EXPERIMENTAL | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part A: Mid Dose | EXPERIMENTAL | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part A: High Dose | EXPERIMENTAL | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part B : Low Dose | EXPERIMENTAL | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part B: Mid Dose | EXPERIMENTAL | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part B: High Dose | EXPERIMENTAL | Participants who are homozygous for the PNPLA3 rs738409:G risk allele will be randomized 1:1:1:1 |
| Part C: Placebo (Optional) | PLACEBO_COMPARATOR | Sponsor may elect to enroll participants who are heterozygous for the PNPLA3 rs738409:G risk allele and may be randomized 1:1 |
| Part C: High Dose (Optional) | EXPERIMENTAL | Sponsor may elect to enroll participants who are heterozygous for the PNPLA3 rs738409:G risk allele and may be randomized 1:1 |
| Part A: Cohorts | EXPERIMENTAL | - |
| Part A: Optional Cohort | EXPERIMENTAL | - |
| Part A: JPN Cohorts | EXPERIMENTAL | - |
| Part B: Cohorts | EXPERIMENTAL | - |
| Part C: Cohorts | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALN-PNP | DRUG | Administered per the protocol |
| Tirzepatide | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol Placebo matching ALN-PNP |
| Placebo (PB) | DRUG | Administered per the protocol |
Key Inclusion Criteria: Part A and Part B: 1. Homozygous for the PNPLA3 p.I148M genotype 2. Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3 3. Has a Body Mass Index (BMI) ≥30 to \<45 kg/m\^2 at visit 2 Part A: To be eligible for randomization on stud...
ALN-PNP is an investigational small molecule being developed for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Nonalcoholic Fatty Liver Disease (NAFLD). It is also being studied in healthy volunteers. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
ALN-PNP is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety and tolerability of ALN-PNP in adults with MASLD and NAFLD.
ALN-PNP is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Clinical trials are ongoing to assess its safety, tolerability, and how it works in patients with MASLD and NAFLD.
ALN-PNP is being studied in several clinical trials. NCT05648214 is a Phase 1 trial in healthy adults and participants with MASLD. NCT06024408 is a completed Phase 1 trial in adults with NAFLD and a genetic risk factor. NCT07527910 is a Phase 2a trial in patients with homozygous PNPLA3-related MASLD.
ALN-PNP is a distinct investigational drug candidate. It is being studied alone and in combination with a GLP1R agonist in a Phase 2a trial for MASLD. No alternative names for ALN-PNP have been reported in the clinical trial information available.