Phase 2
Completed N=101
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Fatty Liver, Nonalcoholic · Non-Alcoholic Fatty Liver Disease · Metabolic Dysfunction-Associated Steatohepatitis · Digestive System Diseases
Source: ClinicalTrials.gov NCT03656744 ↗
Enrolled (actual)
101
Serious AEs
3.0%
Results posted
Dec 2021
Primary outcomePrimary: Absolute Change in Liver Fat Content (LFC) as Measured by MRI-PDFF — -2.918; -4.829; -1.962 Change in percentage of liver fat — p=0.199
Summary
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Liver Fat Content (LFC) as Measured by MRI-PDFF |
-2.918; -4.829; -1.962 | 0.199 |
| SECONDARY Change in Fasting Glucose |
120; 129; 131 | 0.152 |
| SECONDARY Changes in Hemoglobin A1c |
-0.3; -0.6; 0.1 | 0.034 sig |
| SECONDARY Proportion of Subjects Who Achieved ≥ 30% Relative Reduction in LFC as Measured by MRI-PDFF |
6; 10; 7 | 0.884 |
| SECONDARY Relative Change in LFC as Measured by MRI-PDFF |
-15.097; -24.140; -8.322 | 0.196 |
| SECONDARY Number of Subjects Who Normalized LFC to <5% as Measured by MRI-PDFF |
1; 0; 0 | 0.294 |
| SECONDARY Number of Subjects Who Achieved ≥5% Absolute Reduction in Liver Fat Content (LFC) as Measured by MRI-PDFF |
10; 12; 8 | 0.287 |
| SECONDARY Change in HOMA-IR |
-3.38; -4.21; -6.66 | 0.201 |
| SECONDARY Change in LDL-c |
5; -16; 0 | 0.955 |
| SECONDARY Change in Serum Triglycerides |
-41; -24; 18 | 0.041 sig |
| SECONDARY Change in HDL-c |
1; 0; 0 | 0.955 |
| SECONDARY Change in AST |
0; -13; -3 | 0.488 |
| SECONDARY Change in ALT |
-4; -19; -3 | 0.674 |
| SECONDARY Proportion of Subjects With Elevated ALT at Baseline Who Normalized ALT at Week 18 |
3; 9; 5 | 0.588 |
| SECONDARY Change in Pro-Peptide of Type III Collagen (Pro-C3) |
0.5; -2.3; -0.8 | 0.236 |
| SECONDARY Change in ELF Score |
0.05; -0.10; -0.05 | 0.267 |
| SECONDARY Change in TIMP-1 |
1.8; -8.9; -6.0 | 0.387 |
| SECONDARY Change in PIIINP |
0.68; 0.03; -0.31 | 0.107 |
| SECONDARY Change in HA |
-0.64; -5.25; -3.83 | 0.515 |
| SECONDARY Change in Total Bile Acids |
1307; 1625; -581 | 0.003 sig |
| SECONDARY Change in FGF19 |
-11; -9; -40 | 0.124 |
| SECONDARY Number of Participants Reporting an Adverse Events From Baseline Through Week 18 |
21; 26; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of NASH as assessed by MRI
- Clinically documented diagnosis of T2DM
- Body mass index (BMI) >25 kg/m2
Exclusion Criteria
- Liver disease unrelated to NASH
- Poorly controlled T2DM or Type 1 Diabetes Mellitus
- History of alcohol or substance abuse or dependence
- Inability to undergo MRI for any reason
- History of significant cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT03656744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.