China-based Huadong Medicine Co., Ltd (SHE: 000963) announced positive results from the Phase Ia/Ib study of HDM1005, a long-acting agonist targeting the GLP-1 and GIP receptors, in China.
Study Details
- Phase Ia: 64 healthy subjects were enrolled.
- Phase Ib: 40 overweight or obese subjects were enrolled.
Safety Results
The most common adverse reactions were decreased appetite and gastrointestinal issues (nausea, vomiting, bloating), which were mild to moderate and dose-dependent. No grade 3 hypoglycemia, serious adverse events, or premature withdrawals due to adverse events were reported.
Efficacy Results
- Glucose Tolerance: A significant decrease in the area under the curve (AUC) of glucose blood concentration at 0-2 hours was observed in the oral glucose tolerance test (OGTT), with a dose-dependent effect.
- Weight Loss:
- Phase Ia: Maximum average weight loss of 3.92 kg (5.36%) in the 5 mg group at day 8.
- Phase Ib: After 4 weeks of treatment, the 0.5-4.0 mg group showed an average weight loss of 4.79-7.76 kg (6.12% – 10.29%) at day 29, with weight loss maintained 4 weeks after treatment cessation.
- 87.5% of subjects in the HDM1005 group lost more than 5% of their body weight at week 4, compared to 25% in the placebo group.
- Lipid Levels: HDM1005 reduced total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) at week 4.Fineline Info & Tech
