On December 7, Innovent announced that the glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist IBI362 ( LY3305677) multiple-dose, dose-escalated phase Ib clinical study in Chinese type 2 diabetes patients was accepted by the 2021 International Diabetes Federation Conference (IDF 2021) as a conference abstract and published in the form of an online poster
.
The study is a randomized, double-blind, placebo-controlled Phase Ib clinical study, which aims to evaluate the safety, tolerability and pharmacokinetics of IBI362 multiple dose escalation administration in Chinese type 2 diabetes patients with poor blood glucose control.
Pharmacodynamic characteristics, and dulaglycotide was established as an open-label active control group
.
The study was divided into 3 cohorts.
Each cohort enrolled 14 subjects.
They were randomly assigned to receive IBI362, placebo or 1.
5 mg dulaglutide at 8:4:2, and were administered by subcutaneous injection once a week for continuous administration.
12 weeks
.
IBI362 or placebo is administered in a dose titration schedule of 1.
0-2.
0-3.
0 mg (cohort 1), 1.
5-3.
0-4.
5 mg (cohort 2) or 2.
0-4.
0-6.
0 mg (cohort 3), at each dose level 4 weeks
.
The results of the study showed that IBI362 was well tolerated.
The most commonly reported adverse events during the treatment period were loss of appetite and gastrointestinal-related adverse events, and most of the events were transient and mild
.
At week 12, the mean changes in HbA1c level from baseline of subjects in cohorts 1, 2 and 3 who received IBI362 were −1.
46%, −2.
23%, and −1.
66%, respectively.
The dulaglutide group was − 1.
98%
.
Considering that the variation caused by the limited sample size may have an impact on the results, after excluding the maximum and minimum changes in the level of glycosylated hemoglobin from baseline in each administration group at week 12, cohorts 1, 2 and 3 received IBI362 The adjusted mean values of the changes in glycosylated hemoglobin levels from baseline in the treated subjects were −1.
46%, −2.
28%, and −1.
87%, respectively, and −1.
46% in the dulaglutide group
.
At the same time, the average body weight of subjects treated with IBI362 in cohorts 1, 2, and 3 decreased by 0.
9%, 5.
0%, and 5.
4% from baseline at week 12, and the dulaglutide group decreased by 0.
9%
.
The waist circumference, body mass index, blood pressure and blood lipids of subjects treated with IBI362 have also been observed to improve to varying degrees, and the overall trend is similar to that of the IBI362 1b weight loss study [1]
.
Note: The original text has been deleted
Reference materials:
[1] Ji L, Jiang H, An P, et al.
(2021) IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled , multiple ascending dose phase 1b study.
EClinicalMedicine 39: 101088.
10.
1016/j.
eclinm.
2021.
101088
