Evidence map›Paper›PMID 38948164›Full record

ArticleThe Lancet regional health. Western Pacific2024

Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial.

Xiang Yan, Jianhua Ma, Yan Liu, Xuhong Wang, Sheli Li, Shuang Yan, Zhaohui Mo, Yikun Zhu, Jingna Lin, Jie Liu and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet regional health. Western Pacific, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
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

15 authors.

Xiang YanNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Jianhua MaDepartment of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Yan LiuEndocrinology Department, The Third People's Hospital of Datong, Datong City, Shanxi Province, China.
Xuhong WangEndocrinology Department, The First Hospital of Qiqihar, Qiqihar, Heilongjiang, China.
Sheli LiEndocrinology and Metabolism Department, Yan'an University Affiliated Hospital, Baota District, Yan'an, China.
Shuang YanEndocrinology Department, The Fourth Affiliated Hospital of Harbin Medical University, Nangang District, Harbin City, China.
Zhaohui MoEndocrinology Department, The Third Xiangya Hospital of Central South University, Yuelu District, Changsha, China.
Yikun ZhuEndocrinology Department, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Jingna LinEndocrinology Department, Tianjin People's Hospital, Hongqiao District, Tianjin, China.
Jie LiuEndocrinology Department, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China.
Ying JiaMedical Department, Clinical Development Center, PegBio Co., Ltd, Suzhou, China.
Li LiuMedical Department, Clinical Development Center, PegBio Co., Ltd, Suzhou, China.
Ke DingMedical Department, Clinical Development Center, PegBio Co., Ltd, Suzhou, China.
Michael XuMedical Department, Clinical Development Center, PegBio Co., Ltd, Suzhou, China.
Zhiguang ZhouNational Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Type 2 diabetes (T2DM) remains a challenge to treat despite the expansion of various therapeutic classes. Visepegenatide (PB-119) is a once a week, subcutaneous, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection without the requirement of dose titration that has shown glycaemic control and safety profile in two phase 2 studies conducted in China and the United States, respectively. The aim of this study was to evaluate the efficacy and safety of visepegenatide as a monotherapy in treatment-naïve patients with T2DM. Methods: This was a multicentre, double-blind, parallel, placebo-controlled, phase 3 trial conducted in 30 centres in China. Adult participants (aged 18-75 years) with T2DM, glycated haemoglobin (HbA1c) of 7.5%-11.0% [58.47-96.73 mmol/mol], body mass index (BMI) of 18-40 kg/m Findings: Between November 2, 2020, and November 2, 2022, we randomly assigned 273 adult participants to the visepegenatide (n = 137) and placebo (n = 136) groups. In total, 257 (94.12%) participants, 131 (95.6%) on visepegenatide, and 126 (92.6%) on placebo, completed the double-blinded treatment period. At baseline, the mean (SD) HbA1c was 8.47% (0.81) [69.07 [8.81] mmol/mol], which rapidly decreased to 7.63% (0.80) [59.94 [8.70] mmol/mol] with visepegenatide by week 4 of treatment, and the change from baseline was significantly greater than that in the placebo group (-0.82% [-0.90 to -0.74]; [-8.99 [-9.89 to -8.10] mmol/mol] Interpretation: As a monotherapy, visepegenatide provided rapid without the risk of hypoglycaemia, significant, and sustainable glycaemic control by improving islet β-cell function and insulin resistance. Treatment with visepegenatide induced early treatment response in reducing HbA1c and maintaining glycaemic control for 52 weeks. Meanwhile, visepegenatide provided a comprehensive benefit in body weight loss, lipids, and blood pressure reduction. Visepegenatide had a better safety profile than other weekly GLP-1 RA in participants with T2DM even without the requirement of dose titration. Visepegenatide would provide an optimal treatment approach with its high benefit and low-risk balance. Funding: PegBio Co., Ltd.

Indexed as

BMIDiabetesGLP-1 RAGlycaemic controlHbA1cVisepegenatide

Identifiers

PMID38948164
PMCPMC11214404

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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.