Trial reportNature communications2021
A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes.
Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 71 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM
Assess the Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and Non-alcoholic Fatty Liver Disease
Who cites it
71 citing papers in PubMed, 8 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- The effect of berberine on obesity indices: a systematic review and meta-analysis.International journal of obesity (2005) · 2026Pooled it
- Mapping the knowledge domain: a bibliometric analysis of global research on traditional Chinese medicine for non-alcoholic fatty liver disease (2000-2024).Frontiers in medicine · 2026Pooled it
- Berberine and health outcomes: an overview of systematic reviews.BMC complementary medicine and therapies · 2025Pooled it
- Evolution of characteristics of MASLD with and without diabetes: a meta-analysis of placebo arms.Scientific reports · 2024Pooled it
- Berberine Effects in Pre-Fibrotic Stages of Non-Alcoholic Fatty Liver Disease-Clinical and Pre-Clinical Overview and Systematic Review of the Literature.International journal of molecular sciences · 2024Pooled it
- The clinical efficacy and safety of berberine in the treatment of non-alcoholic fatty liver disease: a meta-analysis and systematic review.Journal of translational medicine · 2024Pooled it
- Pooled it
- The effects of berberine supplementation on cardiovascular risk factors in adults: A systematic review and dose-response meta-analysis.Frontiers in nutrition · 2022Pooled it
- Chiglitazar in MASLD with hypertriglyceridemia and insulin resistance: A phase II, randomized, double-blind, placebo-controlled study.Hepatology (Baltimore, Md.) · 2026Trial
- Berberine and Adiposity in Diabetes-Free Individuals With Obesity and MASLD: A Randomized Clinical Trial.JAMA network open · 2026Trial
- Berberine for preventing colorectal adenoma recurrence and neoplasm occurrence: 6-Year follow-up of a randomized clinical trial.Cell reports. Medicine · 2025Trial
- HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study.Clinical and molecular hepatology · 2025Trial
- Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Berberine and its derivatives as candidate modulators of immunosenescence: a critical evaluation.Biogerontology · 2026Review
- Natural Bioactive Compounds Targeting Key Hallmarks of Aging: Functional Food Potential of Spermidine, Fisetin, Berberine, and Urolithin A.Nutrients · 2026Review
- Safety and metabolic effects of HTD1801 in type 2 diabetes and MASLD: a phase Ib randomized trial.Diabetology & metabolic syndrome · 2026Article
- TCM-based natural products in type 2 diabetes: a comprehensive review of bioactive compounds and molecular mechanisms.Molecular diversity · 2026Review
- Current Drug Development Pipeline for MASLD and MASH: Focusing on Cardiovascular Comorbidities.Biomedicines · 2026Review
- "Surrogates without substance?" Questioning the evidence for histologic improvement with HTD1801: Letter to the editor on "HTD1801 demonstrates promising potential for histologic improvements in metabolic dysfunction-associated steatohepatitis in both a preclinical and phase 2 study".Clinical and molecular hepatology · 2026Article
- Current management of MASLD in type 2 diabetes.Hormones (Athens, Greece) · 2026Review
11 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Non-alcoholic steatohepatitis is frequently associated with diabetes and may cause progressive liver disease. Current treatment options are limited. Here we report on a prospective, randomised, double-blind, placebo-controlled trial of two doses of HTD1801 (berberine ursodeoxycholate, an ionic salt of berberine and ursodeoxycholic acid), versus placebo that was conducted in 100 subjects with fatty liver disease and diabetes (NCT03656744). Treatment was for 18 weeks with a primary endpoint of reduction in liver fat content measured by magnetic resonance imaging proton density fat fraction. Key secondary endpoints included improvement in glycemic control, liver-associated enzymes and safety. The pre-specified primary endpoint was met. Thus, subjects receiving 1000 mg twice a day of berberine ursodeoxycholate had significantly greater reduction in liver fat content than in placebo recipients (mean absolute decrease -4.8% vs. -2.0% (p = 0.011). Compared to placebo, subjects receiving this dose also experienced significant improvement in glycemic control as well as reductions in liver-associated enzymes and significant weight loss. Diarrhea and abdominal discomfort were the most frequently reported adverse events. We conclude that berberine ursodeoxycholate has a broad spectrum of metabolic activity in patients with presumed NASH and diabetes. It is relatively well tolerated and merits further development as a treatment for NASH with diabetes.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.