Obese or overweight participants receiving bi-weekly doses of 12 mg,18 mg,24 mg,48 mg,and once-weekly dose of 24 mg GZR18 for 30 weeks achieved mean percent changes in body weight from baseline of -11.15%,-13.22%,-14.25%,-17.29%,and -17.78%,respectively,with the placebo group at -0.99%; and at 30 weeks,participants' body weight continued to decrease.
The clinical efficacy and safety of bi-weekly 48 mg and once-weekly 24 mg GZR18 injections were comparable,with no significant difference in mean percent change in body weight from baseline between the two groups (one-sided test,P > 0.025).
GZR18 injections were safe and well tolerated,with the most commonly reported adverse events being gastrointestinal reactions,comparable to similar drugs.
BEIJING,Nov. 11,2024 -- Gan & Lee Pharmaceuticals (Gan & Lee,Shanghai Stock Exchange: 603087) announced that the results of the Phase 2b clinical study of GZR18 injection,a bi-weekly (twice a month) glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by the company,in adult overweight/obese patients in China were presented as an oral presentation at ObesityWeek®️ 2024.
Statement:
GZR18 is an investigational drug and is not approved for use in any country.
Gan & Lee Pharmaceuticals does not endorse the use of any unapproved drug or indication.
The Phase 2b clinical trial (CTR20231695) was a multicenter,randomized,double-blind,placebo-controlled,dose-finding study designed to evaluate the efficacy and safety of bi-weekly (Q2W) and once-weekly (QW) dosing regimens of GZR18 injection. The study enrolled a total of 340 participants,all of whom were obese (BMI≥28 kg/m²) or overweight (BMI≥24 kg/m²) with at least one weight-related comorbidity and whose weight was poorly controlled by diet and exercise. Participants were randomly assigned to receive 12 mg (n=52),18 mg (n=53),24 mg (n=52),48 mg (n=64) GZR18 injections bi-weekly,or 24 mg (n=53) once-weekly GZR18 injection,or placebo (n=66) for 30 weeks (including a dose escalation period). The primary efficacy endpoint was the percentage change in body weight from baseline after 30 weeks of treatment.
The study results showed a significant reduction in body weight from baseline at week 30 in participants receiving different doses and dosing frequencies of GZR18 injection,with weight loss not yet reaching a plateau. In the Q2W GZR18 dose groups,participants experienced dose-dependent weight loss: 11.15% (1.04) in the 12 mg group,13.22% (0.95) in the 18 mg group,14.25% (1.01) in the 24 mg group,and 17.29% (0.99) in the 48 mg group. In the QW 24 mg group,participants experienced a weight reduction of 17.78% (1.01),while the placebo group showed only a -0.99% (0.91) change. Moreover,there was no significant difference in efficacy between the 48 mg Q2W and 24 mg QW groups (one-sided test P>0.025). In the 48 mg Q2W GZR18 group,the proportions of participants achieving ≥5%,10%,and 20% weight loss were 97.8%,82.2%,and 37.8%,respectively.
GZR18 injection was safe and well tolerated,with the most common adverse events being mild to moderate gastrointestinal reactions. No serious adverse events were reported in any treatment group.
*Trial data are presented as mean (standard error).
The detailed results of the Phase 2b study of GZR18 Injection will be published in a peer-reviewed journal.
Dr. Zhong-ru Gan,Chairman of Gan & Lee Pharmaceuticals,commented:
"The results of this Phase 2b study further validate the excellent performance of GZR18 injection in weight management,particularly with the bi-weekly dosing regimen,which has shown comparable efficacy to the once-weekly regimen. The bi-weekly formulation of GLP-1 has the potential to enhance patient adherence,thereby improving long-term weight management outcomes. GZR18 injection,as the first single-target GLP-1 biweekly formulation,clinical data has demonstrated weight loss effects comparable to or even better than multi-target GLP-1 once-weekly formulations,providing new insights for the future development of GLP-1 drugs. The development of the bi-weekly GZR18 injection is expected to offer more flexible treatment options for patients with obesity,and we look forward to further validating these findings in the upcoming Phase 3 clinical trials."
Forward-looking statements
Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors,and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements,whether as a result of new information,future events,or otherwise.
About Gan & Lee
Gan & Lee Pharmaceuticalsdeveloped the first Chinese domestic insulin analog. Currently,Gan & Lee hassix core insulin products,including five insulin analog varieties: long-acting glargine injection (Basalin®),fast-acting lispro injection (Prandilin™),fast-acting aspart injection (Rapilin®),mixed protamine zinc lispro injection (25R) (Prandilin™25),aspart 30 injection (Rapilin®30),and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30).The companyhas two approved medical devices in China,namelyreusable insulin injection pen(GanleePen),anddisposable pen needle (GanleeFine®).
InChina's2024 National Insulin-Specific Centralized Procurement,Gan & Lee Pharmaceuticals rankedfirst among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets,with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets.
In the future,Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company,Gan & Lee will also actively develop new chemical entities and biological drugs,focusing on treatments for metabolic diseases,cardiovascular diseases,and other therapeutic areas.
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