Evidence map›Paper›PMID 42423945›Full record

Trial reportAdvances in therapy2026

Pharmacokinetics, Pharmacodynamics, and Safety of Once-Weekly Insulin Efsitora Alfa in Chinese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial.

Hui Liu, Yuxin Fan, Yihui Wang, Yuan Yuan, Jennifer K Leohr, Ming Liu, Yerong Yu

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05596747 (Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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.

NCT05596747 phase1completednot on this map

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorEli Lilly and CompanyRan2022 to 2023Enrolled31ConditionsDiabetes Mellitus, Type 2ArmsLY3209590, Insulin Glargine
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

7 authors.

Hui Liu *West China Hospital of Sichuan University, Chengdu, China.
Yuxin Fan *General Hospital of Tianjin Medical University, Tianjin, China.
Yihui WangEli Lilly (Suzhou) Pharmaceuticals Co. Ltd., Shanghai, China.
Yuan YuanEli Lilly (Suzhou) Pharmaceuticals Co. Ltd., Shanghai, China.
Jennifer K LeohrEli Lilly and Company, Indianapolis, IN, USA.
Ming LiuGeneral Hospital of Tianjin Medical University, Tianjin, China.
Yerong YuWest China Hospital of Sichuan University, Chengdu, China. yerongyu@scu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn China, the prevalence of type 2 diabetes mellitus (T2DM) is high, and for those treated with daily basal insulin regimens, suboptimal adherence is common. Once-weekly (QW) basal insulin, such as insulin efsitora alfa (efsitora), may improve treatment adherence and reduce burden. This phase 1 study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of QW efsitora versus once-daily (QD) insulin glargine in Chinese patients with T2DM.

methodsIn this randomized, open-label, active-controlled, multiple-dose study, adults with T2DM on stable basal daily insulin (± non-insulin antihyperglycemic medication) randomized 2:1 to receive QW efsitora or QD glargine for 6 weeks. PK parameters were assessed using non-compartmental analysis. PD endpoints included fasting plasma glucose, 7-point self-monitored blood glucose, HbA1c, and lipid profiles. Safety was evaluated by incidence and severity of treatment-emergent adverse events (TEAEs), hypoglycemia, and immunogenicity.

resultsThirty-one patients (mean age 59.2 years; 58.1% male) were enrolled (efsitora, n = 21; glargine, n = 10). Efsitora exhibited a prolonged elimination half-life (~ 15 days), with apparent clearance of 0.0195 L/h, and apparent volume of distribution of 10.1 L. Both groups showed comparable reductions in fasting glucose and stable daily glucose profiles. No apparent changes in HbA1c were observed. Lipid profiles and C-peptide levels remained stable overall. TEAEs occurred in 81.0% (efsitora) and 80.0% (glargine) of patients, all mild or moderate; no deaths or discontinuations were reported. Hypoglycemic events were mostly asymptomatic and resolved with self-treatment. No treatment-emergent anti-drug antibodies were detected.

conclusionOnce-weekly efsitora demonstrated promising PK and PD profiles and glycemic control comparable to once-daily glargine, with a similar safety profile, in Chinese patients with T2DM. These findings support further investigation of efsitora as a once-weekly basal insulin option in this population.

trial registrationClinicalTrials.gov identifier: NCT05596747.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsInsulin GlargineAdultAgedBlood GlucoseChinaDrug Administration ScheduleEast Asian PeopleFemaleGlycated HemoglobinHumansInsulinsMaleMiddle AgedRecombinant Fusion ProteinsBlood GlucoseEfsitoraGlycated HemoglobinHypoglycemic AgentsInsulin GlargineInsulinsRecombinant Fusion ProteinsChinese patientsInsulin efsitora alfaInsulin glargineOnce-daily insulinOnce-weekly insulinPharmacodynamicsPharmacokineticsSafetyType 2 diabetes mellitus

Identifiers

PMID42423945

What Socratic holds

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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.