18 and older, any sex, with Non-alcoholic Fatty Liver Disease or Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52Primary· From baseline up to week 52
Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint.
The NASH CRN Histologic Scoring System comprised:
steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4)
* Stage 0 - None;
* Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;
* Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis;
* Stage 1c - Portal/pe
Group
Value
95% CI
CC-90001 100mg
15.4
1.92 – 45.45
CC-90001 200mg
0
0 – 21.80
CC-90001 400mg
7.7
0.19 – 36.03
Placebo
6.7
0.17 – 31.95
Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52Secondary· From baseline up to week 52
Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint.
The NASH CRN Histologic Scoring System comprised:
steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4)
* Stage 0 - None;
* Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis;
* St
Group
Value
95% CI
CC-90001 100mg
15.4
1.92 – 45.45
CC-90001 200mg
0
0 – 21.80
CC-90001 400mg
7.7
0.19 – 36.03
Placebo
6.7
0.17 – 31.95
Percentage of Participants With Improvement in Total NASSecondary· From baseline up to week 52
Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Group
Value
95% CI
CC-90001 100mg
7.7
0.19 – 36.03
CC-90001 200mg
6.7
0.17 – 31.95
CC-90001 400mg
15.4
1.92 – 45.45
Placebo
13.3
1.66 – 40.46
Percentage of Participants With Resolution of NASHSecondary· From baseline up to week 52
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52.
Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.
Group
Value
95% CI
CC-90001 100mg
15.4
1.92 – 45.45
CC-90001 200mg
0
0.00 – 21.80
CC-90001 400mg
7.7
0.19 – 36.03
Placebo
6.7
0.17 – 31.95
Percentage of Participants With Resolution of NASH With no Worsening of Liver FibrosisSecondary· From baseline up to week 52
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52
Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Group
Value
95% CI
CC-90001 100mg
15.4
1.92 – 45.45
CC-90001 200mg
0
0.00 – 21.80
CC-90001 400mg
7.7
0.19 – 36.03
Placebo
6.7
0.17 – 31.95
Percentage of Participants Who Progressed to CirrhosisSecondary· From baseline up to week 52
Percentage of participants who progressed to cirrhosis
Group
Value
95% CI
CC-90001 100mg
0
0 – 24.71
CC-90001 200mg
0
0.00 – 21.80
CC-90001 400mg
7.7
0.19 – 36.03
Placebo
6.7
0.17 – 31.95
Mean Change From Baseline in Liver BiochemistrySecondary· From baseline up to week 52
Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)
ALT (U/L)
Group
Value
95% CI
CC-90001 100mg
26.0
± 19.80
CC-90001 400mg
-22.3
± 14.19
Placebo
-6.5
± 21.92
AST (U/L)
Group
Value
95% CI
CC-90001 100mg
9.5
± 10.61
CC-90001 400mg
-17.0
± 10.15
Placebo
7.0
± 4.24
GGT (U/L)
Group
Value
95% CI
CC-90001 100mg
13.0
± 28.28
CC-90001 400mg
-6.3
± 5.86
Placebo
2.5
± 58.69
Mean Change From Baseline in Metabolic ParametersSecondary· From baseline up to week 52
Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides
HDL (mmol/L)
Group
Value
95% CI
CC-90001 100mg
0.005
± 0.0354
CC-90001 400mg
0.147
± 0.2155
Placebo
0.120
± 0.2687
LDL (mmol/L)
Group
Value
95% CI
CC-90001 100mg
0.970
± 0.4525
CC-90001 400mg
0.623
± 0.3785
Placebo
-1.395
± 1.3223
Triglycerides (mmol/L)
Group
Value
95% CI
CC-90001 100mg
-0.135
± 0.0495
CC-90001 400mg
0.027
± 0.2650
Placebo
-0.805
± 0.5445
CmaxSecondary· Day 1 and at Week 4
Cmax is defined as maximum plasma concentration of the drug
Day 1
Group
Value
95% CI
CC-90001 100mg
501.0
± NA
CC-90001 400mg
2938.8
± 44.94
Week 4
Group
Value
95% CI
CC-90001 100mg
352.0
± NA
CC-90001 400mg
2610.0
± NA
TmaxSecondary· Day 1 and at Week 4
Tmax is defined is the time to maximum plasma concentration
Day 1
Group
Value
95% CI
CC-90001 100mg
2.0
2 – 2
CC-90001 400mg
2.0
2 – 2
Week 4
Group
Value
95% CI
CC-90001 100mg
2.0
2 – 2
CC-90001 400mg
4.0
4 – 4
AUC (0-t)Secondary· Day 1 and at Week 4
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Day 1
Group
Value
95% CI
CC-90001 100mg
2322.7
± NA
CC-90001 400mg
26803.9
± 62.87
Week 4
Group
Value
95% CI
CC-90001 100mg
2530.5
± NA
CC-90001 400mg
20918.8
± NA
AUC tSecondary· Day 1 and at Week 4
Area under the plasma concentration time-curve. AUC over the dosing interval.
Day 1
Group
Value
95% CI
CC-90001 100mg
2322.7
± NA
CC-90001 400mg
27173.7
± 59.71
Week 4
Group
Value
95% CI
CC-90001 100mg
2530.5
± NA
CC-90001 400mg
21182.1
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CC-90001 100 mg
Serious: 2/13 (15%)
Deaths: 0/13
CC-90001 200 mg
Serious: 1/15 (7%)
Deaths: 0/15
CC-90001 400 mg
Serious: 2/13 (15%)
Deaths: 0/13
Placebo
Serious: 0/15 (0%)
Deaths: 0/15
Active Treatment Phase CC-90001 200 mg Following Placebo
Serious: 0/1 (0%)
Deaths: 0/1
Active Treatment Phase CC-90001 400 mg Following Placebo
Serious: 0/1 (0%)
Deaths: 0/1
Serious adverse events (7 terms)
Reaction
System
CC-90001 100 mg
CC-90001 200 mg
CC-90001 400 mg
Placebo
Active Treatment Phase CC-…
Active Treatment Phase CC-…
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
—
—
Appendicitis
Infections and infestations
—
—
—
—
—
—
COVID-19
Infections and infestations
—
—
—
—
—
—
Ligament sprain
Injury, poisoning and procedural complications
—
—
—
—
—
—
Spinal retrolisthesis
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.
This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03958864 — A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjec
· Phase 1
· completed
NCT03742882 — A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compar
· Phase 1
· completed
NCT03363815 — A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin,
· Phase 1
· completed
NCT03142191 — A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 2
· terminated
NCT02510937 — Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 7 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04048876.