Evidence map›Paper›PMID 41107649›Full record

Trial reportClinical pharmacokinetics2025

Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Mellitus.

Qinghua Wang, Fan Jiang, Yulong Xu, Yuyang Lei, Li Zhang, Xiaodong Sun

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04994288 (Efficacy and Safety of Once-weekly Supaglutide Versus Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04994288 phase2 / phase3completednot on this map

Efficacy and Safety of Once-weekly Supaglutide Versus Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

TypeinterventionalSponsorShanghai Yinnuo Pharmaceutical Technology Co., Ltd.Ran2021 to 2023Enrolled547ConditionsType2 DiabetesArmsSupaglutide injection, placebo injection
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Trial
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

6 authors.

Qinghua WangInnogen Pharmaceutical Technology Co., Ltd., No. 501, Building 10, 299 Bi Bo Road, Shanghai, 201203, China. qh_wang@fudan.edu.cn.
Fan JiangInnogen Pharmaceutical Technology Co., Ltd., No. 501, Building 10, 299 Bi Bo Road, Shanghai, 201203, China.
Yulong XuInnogen Pharmaceutical Technology Co., Ltd., No. 501, Building 10, 299 Bi Bo Road, Shanghai, 201203, China.
Yuyang LeiInnogen Pharmaceutical Technology Co., Ltd., No. 501, Building 10, 299 Bi Bo Road, Shanghai, 201203, China.
Li ZhangHuashan Hospital, Shanghai Medical College, Fudan University, Shanghai, 200040, China.
Xiaodong SunDepartment of Endocrinology and Metabolism, Affiliated Hospital of Shandong Second Medical University, Weifang, 261031, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEfsubaglutide alfa is a novel glucagon-like peptide-1 receptor agonist composed of dual GLP-1 molecules fused with the fragment crystallizable (Fc) region of human immunoglobulin G2. It is designed for the treatment of type 2 diabetes mellitus (T2DM) and metabolic diseases.

objectivesThis study aimed to quantitatively describe the exposure-response (E-R) relationship between efsubaglutide alfa exposure and efficacy and safety endpoints in patients with T2DM and to assess the impact of baseline characteristics on the E-R relationship.

methodsAn E-R analysis was conducted using data from 465 drug-naïve participants with T2DM in a phase IIb/III trial (YN011-301), which included a 24-week double-blind period followed by a 28-week open-label period. Participants received once-weekly subcutaneous injections of efsubaglutide alfa 1 mg, 2 mg, or 3 mg or placebo. Regression analysis was performed against the steady-state pharmacokinetic exposure, including steady state peak concentration (C

resultsThe median age was 51.0 years, and the mean baseline glycated hemoglobin (HbA1c) was 8.71%. At weeks 24 and 52, reductions in HbA1c, fasting plasma glucose, area under the concentration-time curve for glucose during the mixed-meal tolerance test, body weight, waist circumference, and body mass index correlated positively with drug exposure. The E-R model indicated that a 10-fold increase in C

conclusionsEfsubaglutide alfa demonstrates a strong E-R relationship for glycemic control and weight reduction in drug-naïve participants with T2DM. The extended half-life and favorable safety profile of efsubaglutide alfa make it well-suited for once weekly or biweekly monotherapy in patients with newly diagnosed T2DM.

trial registrationThe trial was registered at Clinicaltrials.gov (identifier: NCT04994288).

Indexed as

Diabetes Mellitus, Type 2Glucagon-Like Peptide 1Hypoglycemic AgentsRecombinant Fusion ProteinsAdultAgedBlood GlucoseDose-Response Relationship, DrugDouble-Blind MethodFemaleGlucagon-Like Peptide-1 Receptor AgonistsGlycated HemoglobinHumansImmunoglobulin Fc FragmentsMaleMiddle AgedBlood GlucoseGlucagon-Like Peptide 1Glucagon-Like Peptide-1 Receptor AgonistsGlycated HemoglobinHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion Proteins

Identifiers

PMID41107649

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.