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Today (October 17), Innovent announced that the results of its high-dose cohort of multiple dose-escalating Phase 1b clinical studies of the investigational glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) double agonist mazdutide (IBI362) in overweight or obese subjects in China have been published
online in The Lancet eClinicalMedicine 。 According to the Cinda Biologics press release, the clinical phase 1 results of the high dose of Mazdutide make it the world's first weight loss of more than 11.
5% in 12 weeks of administration, and the phase 3 study of the product has been fully launched
.
5% within 12 weeks of administration, and the phase 3 study of the product has been fully initiated
Mazdutide is an innovative compound of gastric acid modulator (OXM3) jointly promoted by Innovent and Eli Lilly and Company, which is a GLP-1R and GCGR dual agonist.
As a long-acting synthetic peptide similar to mammalian gastric acid regulators, Mazdutide uses fatty acyl side chains to prolong the duration of action, allowing weekly
administration.
The effect of Mazdutide is thought to be mediated by binding and activation of GLP-1R and GCGR and has a similar mechanism of action to OXM, so it is expected to improve glucose tolerance and reduce body weight
.
In addition to GLP-1R agonists promoting insulin secretion, lowering blood sugar and reducing body weight, mazdutide may also have effects
such as increasing energy expenditure and improving liver fat metabolism through the activation of GCGR.
.
The study published online is a randomized, placebo-controlled clinical study
evaluating the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of multiple dose escalation of Mazdutide in overweight or obese subjects in China.
Low-dose (3 mg, 4.
5 mg, and 6.
0 mg) cohort results were published in The Lancet in 2021
.
Results from the high-dose (9 mg and 10 mg) cohorts
are presented this time.
A total of 24 overweight or obese subjects were enrolled in the high-dose cohort, and 12 subjects in each cohort were randomized to receive a mazdutide dose titration of 2.
5-5.
0-7.
5-10.
0 mg or 3.
0-6.
0-9.
0 mg in a 2:1 ratio or placebo, administered subcutaneously once a week for 4 weeks
at each dose level.
The results of the study showed that Mazdutide titrated to 10 mg and 9 mg was well tolerated, and no participants withdrew from the study
due to adverse events.
No serious adverse events or severe adverse events
occurred.
The most commonly reported adverse events during the treatment period were gastrointestinal adverse events, the vast majority of which were mild
.
After 16 weeks of dosing, subjects treated with Mazdutide in the 10 mg cohort lost an average of 7.
62 kg from baseline (9.
5% reduction); After 12 weeks of dosing, subjects treated with Mazdutide in the 9 mg cohort lost an average of 9.
23 kg (11.
7% decrease)
from baseline.
Improvements in BMI and waist circumference, as well as metabolic markers such as blood pressure, lipids, and blood uric acid, in subjects treated with mazdutide were consistent
with trends observed in low-dose cohorts.
62 kg from baseline (9.
5% reduction); After 12 weeks of dosing, subjects treated with Mazdutide in the 9 mg cohort lost 9.
23 kg from baseline (11.
7% decrease)
Currently, Mazdutide has a number of clinical studies underway, including: 1) a Phase 2 clinical study in obese subjects in China, whose high-dose cohort completed the dosing of the first subject in September 2022; 2) The Phase 3 clinical study in overweight or obese subjects in China has been approved for clinical trial and officially launched
in October 2022.
Professor Ji Linong of Peking University People's Hospital, the lead investigator of the study, said: "I am very pleased to see the successful publication
of the Phase 1 study results of high-dose Mazdutide.
High-dose Mazdutide demonstrated good tolerability and safety, as well as rapid and robust weight loss efficacy in a Phase 1 study, promising to provide severely obese patients with treatment options
comparable to bariatric surgery.
Combined with the results of the Phase 1 and Phase 2 studies of low-dose Mazdutide, Mazdutide has become one of
the most promising innovative weight loss drugs in the world.
I am very confident that Mazdutide will succeed in Phase 3 clinical studies and benefit overweight and obese patients
as soon as possible.
" ”
Dr.
Qian Lei, Vice President of Clinical Development of Innovent Biologics Group, said that the high-dose Phase 1 results of Mazdutide make it the world's first weight loss of more than 11.
5% within 12 weeks of administration, and Innovent is very confident that it will observe more encouraging efficacy in the currently ongoing 9 mg Phase 2 clinical study, laying a good foundation
for its potential alternative to metabolic surgery.
At the same time, Mazdutide's Phase 3 study has been fully launched, and it is expected to provide new treatment options
for overweight and obese patients in China in the near future.
5% within 12 weeks of administration
Resources:
Resources:
[1] The Lancet eClinic Medicine published the results of a high-dose cohort of a Phase Ib clinical study of Mazdutide in overweight or obese subjects in China.
Retrieved Oct 17, 2022, from https://mp.
weixin.
qq.
com/s/mSzI4hB-gb4WyT_DXSBjbA
Retrieved Oct 17, 2022, from https://mp.
weixin.
qq.
com/s/mSzI4hB-gb4WyT_DXSBjbA
[2] 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
(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