Hansoh Pharma Announces Positive Top-Line Results from Phase III Registration Trial of Olatorepatide for Weight Management

On March 7, Hansoh Pharmaceutical Group Company Limited announced that the first Phase III clinical trial (HS-20094-301) of its first weight-loss drug – Oleripetide (HS-20094), a dual agonist of glucagon-like peptide-1 receptor (GLP-1R)/glucose-dependent insulinotropic polypeptide receptor (GIPR), conducted among overweight or obese adult subjects in China, has achieved the primary endpoint.

This randomized, double-blind, placebo-controlled study was conducted across 33 clinical centers in China, enrolling a total of 604 adult subjects to evaluate the efficacy and safety of once-weekly Olerpibat compared to placebo over a 48-week treatment period.

The study met the co-primary endpoints: At 48 weeks of treatment, the weight loss from baseline in the oliceridine group showed a statistically significant difference compared to the placebo group, and the proportion of subjects achieving a 5% weight reduction was significantly higher in the oliceridine group. After 48 weeks of oliceridine treatment, the average weight loss from baseline reached up to 19.3%, with up to 97.2% of subjects achieving a weight reduction of ≥5%.

The study showed that the Oleripetide treatment group exhibited excellent gastrointestinal tolerability, with lower incidence of gastrointestinal adverse events and treatment discontinuation rates compared to the published Phase III trial data of GLP-1-related dual agonists.

"The Phase III clinical data of Olebepin is very encouraging. At 48 weeks, the weight loss was still on a continuous decline, indicating that the drug has the potential to achieve more significant weight reduction effects in long-term use," commented Professor Linong Ji, the principal investigator of the study and Director of the Endocrinology Department at Peking University People's Hospital. "Olebepin not only demonstrates weight loss efficacy comparable to other weight loss drugs targeting the same pathway but also exhibits better gastrointestinal tolerability than other GLP-1 class drugs, which helps improve treatment acceptability and compliance. This is where Olebepin differentiates itself from similar drugs."

"Gastrointestinal tolerance has always been a core obstacle in improving patient treatment compliance," said Ms. Sun Yuan, Executive Director of the Board of Hansoh Pharma. "With its innovative design based on the synergistic action of dual targets, OleyPeptide has not only achieved remarkable weight loss effects but also demonstrated improvements in gastrointestinal tolerance, with an average nausea incidence rate of less than 10% and an average vomiting incidence rate of less than 5%. We believe that OleyPeptide has the potential to become a more 'user-friendly' high-quality new option for overweight and obese populations, and will bring more confidence and possibilities to clinical treatment."

Obesity is a complex chronic disease driven by multiple factors. Currently, more than 650 million adults worldwide are affected, and the World Health Organization (WHO) has long classified it as a public health epidemic in urgent need of addressing. Data from 2025 shows that the combined prevalence of overweight and obesity among Chinese adults has exceeded 50%. As a core risk factor for various chronic diseases, obesity significantly increases the risk of type 2 diabetes, cardiovascular diseases, and even certain cancers, posing profound challenges to public health.

Olebipin is a GLP-1/GIP receptor dual agonist administered once weekly via subcutaneous injection, designed to regulate metabolic pathways associated with appetite control, glucose metabolism, and energy balance. Olebipin is currently undergoing Phase III clinical trials in China for the treatment of obesity/overweight and type 2 diabetes. In June 2025, Hansoh Pharma signed a licensing agreement with Regeneron, granting the latter responsibility for the overseas development of Olebipin.

HS-20094-301 (NCT06839664 / CTR20243973) is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Olepegotide in overweight or obese subjects. After enrollment, subjects are randomly assigned to receive Olepegotide 5 mg, 10 mg, 15 mg, or placebo once weekly for a treatment period of 48 weeks.

It is reported that the detailed data of Olepeptide's Phase III clinical trial for weight loss will be released at future medical academic conferences. Hansoh Pharma plans to submit a new drug application for Olepeptide Injection for long-term weight management in China soon.