Hanmi Pharmaceutical’s investigational obesity drug efeglenatide demonstrated weight loss of up to 30%, according to interim results from a Phase 3 clinical trial.
The company announced on October 27 that it had released topline 40-week data from its ongoing 64-week Phase 3 study of efeglenatide, its in-house-developed GLP-1–based obesity treatment. Hanmi said it disclosed the interim results early with a view to submitting a marketing authorization application in Korea within this year.
The randomized, double-blind, placebo-controlled, parallel-group trial enrolled 448 adults with obesity but without diabetes at multiple university hospitals in Korea. The primary objective was to evaluate the superiority of efeglenatide over placebo in reducing body weight.
At week 40, 79.42% of participants receiving efeglenatide achieved at least 5% weight loss (versus 14.49% for placebo), 49.46% achieved at least 10% (versus 6.52%), and 19.86% achieved at least 15% (versus 2.90%). The mean body-weight reduction was –9.75% with efeglenatide, compared with –0.95% in the placebo group. Some participants experienced weight loss of up to 30% within just 40 weeks.
Hanmi noted that the treatment showed particularly strong efficacy among female participants with a BMI below 30 kg/m², who recorded an average body-weight reduction of –12.20%, the highest among all subgroups analyzed.
Safety results were also favorable. While currently marketed GLP-1 receptor agonists for obesity are often associated with gastrointestinal adverse events such as nausea, vomiting, and diarrhea, the incidence of these side effects was several-fold lower with efeglenatide. The company said this could significantly improve the accessibility and tolerability of anti-obesity treatments.
“Efeglenatide has taken a major step toward becoming a truly ‘national obesity drug’ backed by solid clinical results,” said Na-Young Kim, Executive Vice President and Head of New Product Development at Hanmi Pharmaceutical. “As both the legacy and the beginning of a new era of innovation for Hanmi, efeglenatide will expand beyond obesity into broader metabolic disease areas including diabetes.”
Hanmi plans to complete the ongoing trial and submit a marketing application to the Ministry of Food and Drug Safety (MFDS) in Korea later this year, with the goal of launching the product in the second half of 2026.
In parallel, the company is pursuing the development of Korea’s first “digital-converged medicine”, combining efeglenatide with a digital therapeutic platform. The initiative aims to offer personalized weight-management solutions—covering diet, exercise, and behavioral modification—to support patient adherence and safety throughout obesity treatment.
Hanmi CEO Jae-Hyun Park commented, “The launch of efeglenatide next year will mark a major milestone for Hanmi Pharmaceutical. We will concentrate all our capabilities to ensure the successful commercialization of this first-in-class drug.”
