– ZT002 was safe and well tolerated in both biweekly and monthly dosing arms in patients with overweight or obesity with a tolerability profile aligned with the GLP-1RA class– The open-label extension with ZT002 120 mg, once-monthly, showed 17.1% reduction in body weight at 30 weeks
BEIJING, Sept. 12, 2024 /PRNewswire/ — Beijing QL Biopharmaceutical Co., Ltd. (“QL Biopharm” or the “Company”), a clinical stage biopharmaceutical company developing innovative biologic drugs for the treatment of metabolic diseases, today announces Phase 1c clinical data for its lead drug candidate ZT002 was presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, Madrid, Spain.
The presentation titled ‘ZT002, a novel ultra long-acting GLP-1 receptor agonist in adults with overweight or obesity: A randomized, placebo-controlled, multiple ascending dose phase 1c study’ highlighted recent findings on QL Biopharm’s lead drug candidate ZT002 – a novel ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) in development for obesity with monthly subcutaneous administration.
The study enrolled 28 overweight/obese patients in Part A in two cohorts. Eligible participants were randomly assigned to receive biweekly (Q2W) subcutaneous injections of ZT002 (dose escalated to 40 or 80 mg; n=10+10) or matched placebo (n=4+4) for a 12- or 14- week treatment period, in the 40 mg and 80 mg dose arms, respectively. The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met. Following a 6-week off-drug period, for assessment of pharmacokinetics, Part A was followed by an open-label extension (Part B). In this extension patients from the ZT002 80 mg Q2W cohort voluntarily participated in an additional 12 weeks of treatment with a once-monthly (Q4W) administration of ZT002 120 mg (n=8). The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met.
Key conclusions from today’s presentation are outlined below:
ZT002 was considered safe and well tolerated across the investigated dose range, with a favorable tolerability profile aligned with the GLP-1RA class. The tolerability with both Q2W and Q4W dosing improved over time.
The majority of adverse events (AEs) were mild or moderate in severity, no serious AEs were reported in the ZT002 treatment groups.
Gastrointestinal (GI) treatment emergent adverse events were consistent with the GLP-1RA class;
Most common treatment-related adverse events were nausea, vomiting, and diarrhea, occurring primarily during dose escalation and decreasing once target dose was reached.
The GI AE profile of monthly dosing in Part B appeared similar to biweekly dosing in Part A
In Part A, ZT002 demonstrated statistically significantly higher weight reduction compared to placebo with
13.0% body weight reduction from baseline to 14 weeks with ZT002 80 mg Q2W (p