A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes

Hongwei Jiang, Shuguang Pang, Yawei Zhang, Ting Yu, Meng Liu, Huan Deng, Li Li, Liqi Feng, Baili Song, Han Han-Zhang, Qingyang Ma, Lei Qian () and Wenying Yang ()
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Hongwei Jiang: Henan University of Science and Technology
Shuguang Pang: Jinan Central Hospital
Yawei Zhang: Pingxiang People’s Hospital
Ting Yu: Innovent Biologics, Inc
Meng Liu: Innovent Biologics, Inc
Huan Deng: Innovent Biologics, Inc
Li Li: Innovent Biologics, Inc
Liqi Feng: Innovent Biologics, Inc
Baili Song: Innovent Biologics, Inc
Han Han-Zhang: Innovent Biologics, Inc
Qingyang Ma: Innovent Biologics, Inc
Lei Qian: Innovent Biologics, Inc
Wenying Yang: China-Japan Friendship Hospital

Nature Communications, 2022, vol. 13, issue 1, 1-8

Abstract: Abstract The success of glucagon-like peptide-1 (GLP-1) receptor agonists to treat type 2 diabetes (T2D) and obesity has sparked considerable efforts to develop next-generation co-agonists that are more effective. We conducted a randomised, placebo-controlled phase 1b study (ClinicalTrials.gov: NCT04466904) to evaluate the safety and efficacy of IBI362 (LY3305677), a GLP-1 and glucagon receptor dual agonist, in Chinese patients with T2D. A total of 43 patients with T2D were enrolled in three cohorts in nine study centres in China and randomised in each cohort to receive once-weekly IBI362 (3.0 mg, 4.5 mg or 6.0 mg), placebo or open-label dulaglutide (1.5 mg) subcutaneously for 12 weeks. Forty-two patients received the study treatment and were included in the analysis, with eight receiving IBI362, four receiving placebo and two receiving dulaglutide in each cohort. The patients, investigators and study site personnel involved in treating and assessing patients in each cohort were masked to IBI362 and placebo allocation. Primary outcomes were safety and tolerability of IBI362. Secondary outcomes included the change in glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-mixed-meal tolerance test (post-MTT) glucose levels. IBI362 was well tolerated. Most commonly-reported treatment-emergent adverse events were diarrhoea (29.2% for IBI362, 33.3% for dulaglutide, 0% for placebo), decreased appetite (25.0% for IBI362, 16.7% for dulaglutide, 0% for placebo) and nausea (16.7% for IBI362, 16.7% for dulaglutide and 8.3% for placebo). HbA1c, FPG and post-MTT glucose levels were reduced from baseline to week 12 in patients receiving IBI362 in all three cohorts. IBI362 showed a favourable safety profile and clinically meaningful reductions in blood glucose in Chinese patients with T2D.

Date: 2022
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DOI: 10.1038/s41467-022-31328-x

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