ArticleDiabetology & metabolic syndrome2026
Safety and metabolic effects of HTD1801 in type 2 diabetes and MASLD: a phase Ib randomized trial.
Article in Diabetology & metabolic syndrome, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHTD1801 is a novel compound composed of equal parts berberine (BBR) and ursodeoxycholic acid (UDCA). It functions as a gut-liver metabolic modulator with a unique mechanism of action that may offer therapeutic benefits for patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD).
methodsA total of 48 patients were enrolled in this study. Thirty-six treatment-naïve patients were randomized to receive HTD1801 at doses of 500 mg, 750 mg, or 1000 mg, or placebo, administered twice daily for 28 days. An additional 12 patients on stable metformin therapy were randomized (3:1) to receive either HTD1801 1000 mg or placebo.
resultsHTD1801 was generally well tolerated, with most adverse events classified as mild to moderate in severity. No serious adverse events were reported. Berberine exhibited saturation kinetics, whereas UDCA demonstrated linear pharmacokinetics. Accumulation was low to moderate (range: 0.9673 to 2.6659). Compared to placebo, HTD1801 improved glucose and lipid metabolism and reduced liver enzyme levels. A dose-dependent effect was observed, with metabolic improvements increasing with higher administered doses. In the metformin group, HTD1801 (1000 mg) resulted in greater reductions in fasting glucose (mean absolute decrease: -1.271 vs. +0.423 mmol/L), 2-h postprandial glucose (-4.167 vs. +0.290 mmol/L), LDL-C (-0.623 vs. +0.290 mmol/L), total cholesterol (-1.090 vs. +0.023 mmol/L), and GGT (-9.28 vs. -4.43).
conclusionHTD1801 was safe and demonstrated potential metabolic benefits in patients with T2DM and MASLD. Further investigation is warranted.
trial registrationRetrospectively registered, ChiCTR2500110932 (date: 22nd Oct. 2025), https://www.chictr.org.cn .
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.