Fresh from a $400 million series A round, Kailera Therapeutics has shown off phase 2 data on an obesity candidate it believes can muscle in on the market. Kailera and partner Jiangsu Hengrui Pharmaceuticals linked the injectable GLP-1/GIP receptor dual agonist to 22.8% mean weight loss after 36 weeks.
The data come from a phase 2 trial Hengrui Pharma is running in China. Hengrui Pharma enrolled 61 patients with who are overweight or with obesity but without Type 2 diabetes. Forty-nine of the participants received once-weekly injections of HRS9531, titrating up to 8 mg for 24 weeks and then staying at that level for a further 12 weeks. The other patients received placebo.
After 36 weeks, patients on HRS9531 had lost 22.8% of their body weight. Adjusting for placebo, weight loss was 21.1%. Almost 60% of the patients lost at least 20% of their body weight after taking HRS9531. Weight loss was still increasing at Week 36, implying Kailera and Hengrui Pharma can go past 22.8%.
The data suggest HRS9531 has similar efficacy to Eli Lilly’s Zepbound. Lilly won approval for the drug, which, like HRS9531, hits GLP-1 and GIP, after showing (PDF) patients lost 20.9% of their body weight across 36 weeks of treatment. By Week 88, weight loss had increased to 25.8%. The Lilly trial sets the bar for longer-term updates on HRS9531, which Kailera calls KAI-9531.
Kailera and Hengrui Pharma previously showed the promise of HRS9531 in a phase 2 study that tested doses of up to 6 mg for 24 weeks. Placebo-adjusted mean weight loss in that trial topped out at 16.7%.
The companies are yet to share safety and tolerability data for the 8-mg dose. Most adverse events were mild and consistent with the profile reported for the injectable GLP-1/GIP receptor dual agonist class, the partners said, and gastrointestinal-related side effects occurred primarily during dose titration. At the 6-mg dose, the rates of nausea, diarrhea and vomiting were 33%, 31% and 29%, respectively.
Hengrui Pharma is already running phase 3 trials in obesity and Type 2 diabetes in China. Kailera CEO Ron Renaud said in a statement that his company is “focused on building our clinical and manufacturing teams and infrastructure to advance HRS9531 as KAI-9531 into a global phase 3 program.”