Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07221188 | A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH | PHASE3 | RECRUITING | 1,250 | — | — | Dec 12, 2025 | Mar 24, 2028 | Apr 16, 2026 | 43 | United States |
| NCT07221227 | A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH | PHASE3 | RECRUITING | 1,200 | — | — | Oct 24, 2025 | Dec 12, 2031 | Apr 16, 2026 | 49 | United States |
| NCT07358546 | A Study of Efimosfermin Alfa in Adults With Hepatic Impairment | PHASE1 | RECRUITING | 32 | — | — | Mar 13, 2026 | Oct 13, 2027 | Apr 13, 2026 | 3 | United States |
| NCT07335198 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry | PHASE1 | RECRUITING | 30 | — | — | Mar 5, 2026 | Aug 17, 2026 | Mar 27, 2026 | 1 | New Zealand |
Proportion of participants experiencing improvement in fibrosis of greater than or equal to (\>=) 1 stage by MASH clinical research network (CRN) fibrosis scores and no worsening of steatohepatitis (defined as no increase in nonalcoholic fatty liver disease activity score \[NAS\] for ballooning, inflammation, or steatosis) at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity.
Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis. NAS score ranges from 0 to 8, higher score indicates worse disease activity. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
Liver-related outcome will comprised of all-cause mortality; transplantation; occurrence of significant hepatic events.
| Arm | Type | Description |
|---|---|---|
| Efimosfermin Alfa Dose Level 1 | EXPERIMENTAL | Participants randomized to this group will receive Efimosfermin Alfa at dose level 1 |
| Efimosfermin Alfa Dose Level 2 | EXPERIMENTAL | Participants randomized to this group will receive Efimosfermin Alfa at dose level 2 |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to this group will receive Placebo |
| Participants receiving dose level 1 of efimosfermin alfa | EXPERIMENTAL | - |
| Participants receiving dose level 2 of efimosfermin alfa | EXPERIMENTAL | - |
| Participants receiving Placebo | PLACEBO_COMPARATOR | - |
| Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol | EXPERIMENTAL | All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (\<) 5 standard drinks on any day and \<15 standard drinks per week for men; or \<4 standard drinks on any day and \<8 standard drinks per week for women. |
| Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol | EXPERIMENTAL | All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (\>=) 5 standard drinks per day or \>=15 standard drinks per week for men; or \>= 4 standard drinks per day or \>=8 or more drinks per week for women. |
| Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use | EXPERIMENTAL | All participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption. |
| Efimosfermin alfa in participants of Chinese Ancestry | EXPERIMENTAL | Healthy participants of Chinese ancestry will be randomized to receive efimosfermin alfa. |
| Efimosfermin alfa in participants of Japanese Ancestry | EXPERIMENTAL | Healthy participants of Japanese ancestry will be randomized to receive efimosfermin alfa. |
| Efimosfermin alfa in participants of White/European Ancestry | EXPERIMENTAL | Healthy participants of White/European ancestry will be randomized to receive efimosfermin alfa |
| Placebo in participants of Chinese Ancestry | PLACEBO_COMPARATOR | Healthy participants of Chinese ancestry will be randomized to receive Placebo. |
| Placebo in participants of Japanese Ancestry | PLACEBO_COMPARATOR | Healthy participants of Japanese ancestry will be randomized to receive Placebo. |
| Placebo in participants of White/European Ancestry | PLACEBO_COMPARATOR | Healthy participants of White/European ancestry will be randomized to receive Placebo. |
| Name | Type | Description |
|---|---|---|
| Efimosfermin Alfa | DRUG | Efimosfermin Alfa will be administered |
| Placebo | DRUG | Placebo will be administered |
Inclusion Criteria: * Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures * Age \>=18 through \<=75 years at enrolment * History or presence of 2 or more of the 5 components of metabolic syndrome per America...