Hanmi Pharmaceutical said on the 27th that its obesity drug candidate "efpeglenatide" under development confirmed up to a 30% weight-loss effect in a domestic phase 3 clinical trial.
Efpeglenatide is in the glucagon-like peptide-1 (GLP-1) class and is administered once weekly as a subcutaneous injection (SC) for obesity treatment. Hanmi Pharmaceutical has been conducting a domestic, multicenter phase 3 trial since Dec. 2023 in adult patients with obesity who do not have diabetes.
In total, 448 people were treated over 40 weeks across multiple hospitals in Korea, and 79.4% of those given efpeglenatide lost at least 5% of their body weight, compared with 14.5% in the placebo group.
The proportion who lost at least 10% was 49.46% (placebo 6.52%), and at least 15% was 19.86% (placebo 2.90%). The average weight-loss rate was about 9.75%, roughly 8 percentage points greater than the placebo group (0.95%). Some patients showed a reduction of up to 30% at week 40 of treatment.
The effect was particularly pronounced in female patients with a body mass index (BMI, weight divided by height squared) under 30. This group recorded an average weight-loss rate of 12.2%, the highest among all subgroup analyses.
Adverse events were mainly gastrointestinal symptoms such as nausea, vomiting and diarrhea. Hanmi Pharmaceutical said, "In addition to the excellent efficacy of efpeglenatide, confirming a safety profile of adverse events favorable compared with existing drugs is also a major outcome of this trial."
Hanmi Pharmaceutical plans to apply for domestic marketing authorization within the year based on these results. It will also conduct an additional 24-week extension study after 40 weeks of treatment to evaluate the durability of weight loss with a total of 64 weeks of dosing.
Park Jae-hyun, CEO of Hanmi Pharmaceutical, said, "Efpeglenatide will be a new springboard for Hanmi ahead of its launch next year," adding, "We will focus our capabilities so that other new drugs in the future obesity pipeline (H.O.P, Hanmi Obesity Pipeline) can deliver results in sequence."