- Obese and 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, July 22, 2024 /PRNewswire/ -- Recently, Gan &
Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange:
603087) announced that its independently developed long-acting
GLP-1 receptor agonist (GLP-1 RA), GZR18 injection, has achieved
positive results in a clinical trial for adults with
obesity/overweight in China.
Statement:
1. GZR18 injection is an investigational drug and has
not yet been approved in China.
2. Gan & Lee Pharmaceuticals does not recommend
the use of any unapproved drugs/indications.
The phase IIb clinical trial (CTR20231695) is a multi-center,
randomized, double-blind, placebo-controlled study conducted at 25
clinical trial centers in China,
recruiting a total of 340 participants. The participants were
overweight (BMI≥24 kg/m2) with at least one
weight-related comorbidity or obese (BMI≥28 kg/m2)
adults with poorly controlled diet and exercise. They were
randomized to receive bi-weekly (Q2W) doses of 12 mg, 18 mg, 24 mg,
48 mg, and once-weekly (QW) dose of 24 mg GZR18 injection or
placebo for 30 weeks (including a dose escalation period). The
primary efficacy endpoint of the study was the percent change in
body weight from baseline after 30 weeks of treatment. The study
assessed changes from baseline in average weight, waist
circumference, waist-to-hip ratio, body mass index (BMI), glycemic
parameters, and the safety and tolerability of the drug.
After 30 weeks of treatment, compared to the placebo group,
participants receiving different doses and frequencies of GZR18
injection (12 mg, 18 mg, 24 mg, and 48 mg Q2W; 24 mg QW) had a
significant reduction in the percent change in body weight from
baseline. The mean percent changes in body weight from baseline was
-11.15% (12 mg group, Q2W), -13.22% (18 mg group, Q2W), -14.25% (24
mg group, Q2W), -17.29% (48 mg group, Q2W), and -17.78% (24 mg
group, QW), all more effective than the placebo group (reduced by
0.99%). There was no significant difference in mean percent change
in body weight between the 48 mg Q2W group and the 24 mg QW group
(one-sided test, P > 0.025).
In this study, the bi-weekly GZR18 injections were generally
safe and well tolerated, consistent with the known safety signals
of GLP-1 receptor agonists. The most common adverse events were
gastrointestinal reactions, most of which were mild to moderate in
severity, comparable to other GLP-1 RAs.
The comprehensive results of this phase IIb study are planned to
be announced later this year and will be published in a
peer-reviewed journal.
About Gan & Lee
Gan & Lee Pharmaceuticals developed the first Chinese
domestic insulin analog. Currently, Gan & Lee has six 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 company has two approved medical
devices in China, namely reusable
insulin injection pen (GanleePen), and disposable pen
needle (GanleeFine®).
In China's 2024 National
Insulin-Specific Centralized Procurement, Gan & Lee
Pharmaceuticals ranked second overall and first among domestic
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.
Further Information:
BPRD@ganlee.com (Media)
BD@ganlee.com (Business Development)
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