Innovent Biologics' Once-Weekly Oral GLP-1 Receptor Agonist IBI3042 Granted IND Approval for Obesity Treatment

On August 20, the official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) announced that Innovent’s Class 1 new drug IBI3042 had been approved for clinical trials, intended forWeight Management in Adults with Overweight or Obesity. According to publicly available information from Innovent Biologics, IBI3042 is aOral Small-Molecule GLP-1 Weekly Formulation。

IBI3042 is a novel, once-weekly, oral small-molecule GLP-1 receptor agonist intended for the treatment of type 2 diabetes and obesity. According to the preclinical study results presented by Innovent at the 2026 American Diabetes Association (ADA) Scientific Sessions in June this year:

• Pharmacokinetic and pharmacodynamic profiles of IBI3042, systematically evaluated in hGLP-1 receptor knock-in mice and obese cynomolgus monkey models, indicate that IBI3042 holds promise as a once-weekly oral therapy offering both efficacy advantages and dosing convenience for patients with diabetes and obesity.

• The glucose-lowering efficacy of IBI3042 lasts for one week: In hGLP-1R KI mice, the glucose-lowering effect persisted for at least 7 days after administration of IBI3042 at 0.4 mg/kg.

• IBI3042 demonstrates superior weight-loss efficacy: in humanized GLP-1 receptor knock-in mice with diet-induced obesity (DIO), IBI3042 administered at 1.0 mg/kg twice weekly, compared to the control drug (a once-daily oralSmall-Molecule GLP-1 Receptor Agonists)1.5 mg/kg once daily showed comparable efficacy; a dose of 3.0 mg/kg twice weekly demonstrated superior efficacy.

• In obese cynomolgus monkeys, the weight loss effect of IBI3042 administered once weekly at 7 mg/kg was comparable to that of the control drug administered once daily at 1.0 mg/kg; twice-weekly administration at 1.5 mg/kg and 4.5 mg/kg resulted in dose-dependent weight loss, with the maximum weight loss achieved by the 4.5 mg/kg regimen surpassing that of the control drug administered once daily at 1.0 mg/kg.

Innovent’s previous press release stated that IBI3042 has the potential to enable once-weekly dosing, providing patients with diabetes and obesity with a glycemic control and weight loss solution that offers improved adherence and a higher quality of life.

References:
[1]Once-Daily Oral Dosing at ADA 2026 | Innovent Announces Multiple Research Findings on Next-Generation Innovative Weight Loss and Metabolic Pipeline. From https://mp.weixin.qq.com/s/MGdvLPbHdlspIZA5fNfDWA

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