ProGen has launched a global phase 2b trial of its GLP-1/GLP-2 dual agonist PG-102, setting up a head-to-head comparison with Ozempic as the Korean biotech moves deeper into mid-stage clinical development.
Progen's head office in Gangseo-gu, Seoul (Courtesy of Progen)
The company said Wednesday that Korean and Australian regulators had approved the multinational study in patients with type 2 diabetes.
The active-comparator trial will evaluate the glucose-lowering efficacy of PG-102 against semaglutide, the ingredient in Ozempic, which recently became eligible for reimbursement in Korea for diabetes treatment.
ProGen said the study is designed to support future global regulatory filings and marks the company’s first formally approved global clinical development strategy for PG-102.
The trial will enroll 180 patients with type 2 diabetes across Korea and Australia. Participants will be randomized into three groups receiving either PG-102 at 60 mg once weekly, PG-102 at 90 mg once weekly, or semaglutide 1.0 mg over a 32-week treatment period.
The primary endpoint is glycemic control at week 32. Researchers will also evaluate changes in body weight and body composition, including muscle preservation, as well as safety, gastrointestinal tolerability and bone metabolism biomarkers.
The study includes patients with body mass index (BMI) values ranging from 23 to 40 kg/m², expanding the target population compared with the company’s earlier phase 2a study, which enrolled patients with BMI values between 18.5 and 30 kg/m².
ProGen released phase 2a data in February showing improvements in blood glucose control in patients with type 2 diabetes, including older patients with long disease duration. The company said patients receiving 60 mg every two weeks showed up to a 1.44 percentage-point reduction in HbA1c at week 14.
The company also reported selective fat reduction, preservation of lean body mass and favorable tolerability in the earlier study.
Through the phase 2b trial, ProGen plans to assess whether once-weekly dosing and escalation to 90 mg can improve metabolic efficacy while differentiating PG-102 from semaglutide in glycemic control and body composition effects.
The inclusion of Australian sites is intended to provide more ethnically diverse clinical data and support future late-stage global development and commercialization plans, the company said.
Industry observers view the trial as an important test of the company’s value and development strategy because it directly compares PG-102 against Ozempic, one of the world’s leading diabetes and obesity therapies.
Kim Jong-gyun, co-CEO of ProGen, said the company is positioning PG-102 as a next-generation metabolic disease therapy focused not only on weight loss, but also on glycemic control, body composition and tolerability.
Kim Ji-hye
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