Beijing QL Biopharmaceutical has shared phase 2 data on its once-monthly GLP-1 candidate, providing early evidence that the ultra-long-acting prospect can match the efficacy of weekly products from Eli Lilly and Novo Nordisk.
The phase 2 trial randomized 303 people in China who are overweight or with obesity to receive one of four regimens of the GLP-1 candidate zovaglutide or placebo. Half of the patients, split evenly between 80-mg and 160-mg doses, were on monthly regimens. Another 101 patients received either 80 mg or 160 mg of zovaglutide, also known as ZT002, every two weeks. The remaining 51 patients received placebo.
After 24 weeks, average weight loss in the zovaglutide cohorts ranged from 10.6% to 14.4%, compared to 2.4% in the placebo group. People who received 160 mg of zovaglutide every two weeks lost the most weight. But, at 13.8%, weight loss in the monthly 160-mg cohort was almost as steep. The company, which shortens its name to QL Biopharm, said weight loss was yet to plateau at Week 24.
QL Biopharm said its weight loss was numerically superior to 24-week phase 3 data on Lilly’s tirzepatide and Novo’s semaglutide, although such cross-trial comparisons can be unreliable. The company was comparing its data to results for 2.4 mg of semaglutide, which Novo sells as Wegovy, and 15 mg of tirzepatide, which Lilly sells as Zepbound. Wegovy and Zepbound are administered weekly.
Multiple companies have identified dosing frequency as a way to win market share from Lilly and Novo. Amgen’s MariTide is given monthly. Metsera is aiming to publish monthly data on its GLP-1 candidate MET-097i around the end of the year. Novo stopped development of a monthly dual GLP-1/GIP receptor agonist last year but retains an interest in reducing the frequency of dosing.
QL Biopharm has enabled monthly dosing by making dual-fatty acid chain modifications to the peptide to enhance binding affinity to albumin in the blood. Per pharmacokinetic studies in multiple species, the asset has a two- to fourfold longer half-life than semaglutide. With the midphase efficacy data providing further evidence, the company plans to take the once-monthly regimen through a phase 3 program.
The plan is supported by phase 2 safety and tolerability data. QL Biopharm said the overall incidence of gastrointestinal adverse events was similar to that of marketed GLP-1 drugs and decreased once patients reached the target dose. Giving 160 mg of zovaglutide once a month was associated with a lower rate of gastrointestinal events than administering 80 mg of the molecule every two weeks, the company said.