Evidence map›Paper›PMID 40971152›Full record

Trial reportClinical pharmacology in drug development2026

A multipart phase 1 study of the safety, pharmacodynamics and pharmacokinetics of ALG-055009, a novel thyroid hormone receptor beta (THR-β) agonist for metabolic dysfunction-associated steatohepatitis (MASH), in healthy participants.

Hakim Charfi, Benedetta Massetto, Megan Fitzgerald, Kha Le, Stanley Wang, Ifong Kan-Eng, Meenakshi Venkatraman, Naqvi Mohammad, Lawrence Blatt, Tse-I Lin and 2 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Hakim CharfiBiotrial Rennes, Rennes Cedex, France.
Benedetta MassettoClinical Development, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Megan FitzgeraldClinical Development, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Kha LeClinical Pharmacology, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Stanley WangClinical Development, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Ifong Kan-EngClinical Operations, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Meenakshi VenkatramanCMC, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Naqvi MohammadCMC, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Lawrence BlattAligos Therapeutics, Inc., South San Francisco, CA, USA.
Tse-I LinClinical Development, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
Sushmita M ChandaClinical Development, Aligos Therapeutics, Inc., South San Francisco, CA, USA.
John FryClinical Development, Aligos Therapeutics, Inc., South San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ALG-055009 is an oral thyroid hormone receptor beta (THR-β) agonist being evaluated for treating metabolic dysfunction-associated steatohepatitis (MASH). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALG-055009 and bioavailability/food effect. Part 1 was a single-ascending dose study in healthy participants randomized to ALG-055009 (0.1 to 4.0 mg) or placebo. Part 2 was a multiple-ascending dose study in participants with mild hyperlipidemia randomized to ALG-055009 (0.3 to 1.0 mg) or placebo once daily for 14 days. Part 3 was an open-label study to determine relative bioavailability and food effect of 0.6 mg ALG-055009 solution versus soft gelatin (softgel) capsule formulation. Among 78 participants, ALG-055009 was well tolerated, and most adverse events were mild or moderate with no clinically meaningful safety issues. Transient reductions in thyroid hormone levels were observed with no clinical manifestation of hypo/hyperthyroidism. Plasma ALG-055009 exposure increased in a dose-proportional manner with rapid absorption, low variability, accumulation ranging from 1.6-2.6-fold, and t

Indexed as

Thyroid Hormone Receptors betaAdministration, OralAdultBiological AvailabilityDose-Response Relationship, DrugFemaleFood-Drug InteractionsHealthy VolunteersHumansHyperlipidemiasMaleMiddle AgedThyroid HormonesYoung AdultThyroid Hormone Receptors betaThyroid Hormoneslipidsmetabolic dysfunction–associated steatohepatitispharmacokineticsthyroid hormone receptor beta

Identifiers

PMID40971152
PMCPMC12856969

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Registered trials

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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.