Evidence map›Paper›PMID 40093645›Full record

Trial reportDrug design, development and therapy2025

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of BGT-002, a Novel ATP-Citrate Lyase Inhibitor, in Healthy Chinese Subjects.

Yun Liu, Chengyin Yu, Yifan Zhang, Zhifu Xie, Yating Wang, Hongjie Qian, Liyu Liang, Yanmei Liu, Qian Chen, Jingying Jia and 7 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2025. 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

17 authors.

Yun Liu *Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Chengyin Yu *Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Yifan ZhangState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, People's Republic of China.ORCID 0000-0002-9164-8309
Zhifu XieState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, People's Republic of China.
Yating WangShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Hongjie QianShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Liyu LiangShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Yanmei LiuShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Qian ChenShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.
Jingying JiaShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.ORCID 0000-0002-2492-3219
Sai YanBurgeon Therapeutics Co., Ltd., Shanghai, People's Republic of China.
Xiaoyin LaiBurgeon Therapeutics Co., Ltd., Shanghai, People's Republic of China.
Wei LiBurgeon Therapeutics Co., Ltd., Shanghai, People's Republic of China.
Jingya LiState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, People's Republic of China.
Yangming ZhangBurgeon Therapeutics Co., Ltd., Shanghai, People's Republic of China.
Fajun NanState Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, People's Republic of China.
Chen YuShanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: This Phase I study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BGT-002, a novel ATP-citrate lyase (ACLY) inhibitor, in healthy Chinese adults. Methods: This study included three parts: Part I (single-ascending-dose study), Part II (multiple-ascending-dose study), and Part III (food effect study). A total of 104 healthy subjects were enrolled in the study and were given BGT-002 tablet or placebo per protocol requirements. Blood samples were collected for pharmacokinetic and pharmacodynamic analysis. Safety was assessed by clinical examinations and adverse events. Results: In Part I, BGT-002 demonstrated rapid absorption with a T Conclusion: BGT-002 demonstrated favorable safety, tolerability, and lipid-lowering effects, supporting its potential for further clinical development. Clinical Trial Registration: ChiCTR2200057793(https://www.chictr.org.cn/showproj.html?proj=160210); ChiCTR2300067474(https://www.chictr.org.cn/showproj.html?proj=182183); ChiCTR2300067472(https://www.chictr.org.cn/showproj.html?proj=184079).

Indexed as

ATP Citrate (pro-S)-LyaseEnzyme InhibitorsAdministration, OralAdultDose-Response Relationship, DrugDouble-Blind MethodEast Asian PeopleFemaleHealthy VolunteersHumansMaleMiddle AgedYoung AdultATP Citrate (pro-S)-LyaseEnzyme InhibitorsBGT-002novel ACLY inhibitorpharmacodynamicspharmacokineticssafetytolerability

Identifiers

PMID40093645
PMCPMC11910062

What OpenQuestion holds

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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.