Slide 1: Efficacy and safety of HRS9531 in patients with T2DM: phase 2 trial
Efficacy and safety of HRS9531, a novel dual GLP-1/GIP receptor agonist, in patients with type 2 diabetes mellitus (T2DM): a randomized, double-blind, placebo-controlled phase 2 trial Jiajun Zhao1, Meng Zhao1, Weihong Song2, Dongji Wang3, Xianghua Zhang4, Yuan Hui5, Yanqin Zhou6, Yibing Lu7, Hong Ch
Slide 2: Disclosure
Disclosure • Dr. Hong Chen is an employee of Jiangsu Hengrui Pharmaceuticals. • Prof. Jiajun Zhao declares no potential conflicts of interest.
Slide 3: Background
Background • Accumulating clinical evidence suggests that a dual glucagon-like peptide-1 (GLP-1) and glucose- dependent insulinotropic polypeptide (GIP) receptor agonist can achieve additive or synergetic effects on glycemic control and body weight loss.1-3 • HRS9531 is a novel agonist of both GLP-1
Slide 4: Objective and Study Design
Objective and Study Design • Objective: To evaluate the efficacy and safety of HRS9531 compared with placebo in T2DM patients. • This is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial (NCT05966272). Key Inclusion: – Aged 18–65 years – History of T2DM ≥ 6-month – HbA1c of 7
Slide 5: Baseline Characteristics
Baseline Characteristics • A total of 199 eligible patients (from 37 hospitals in China) were randomized and received assigned treatment. • The baseline demographics and clinical characteristics were generally balanced across the four doses of HRS9531 and the placebo group. HRS9531 HRS9531 HRS9531 H
Slide 6: Primary Endpoint (HbA1c Reduction)
Primary Endpoint (HbA1c Reduction) • At week 20, HbA1c reductions in the four doses group of HRS9531 were all greater than that in the placebo group (p<0.0001 for all comparisons with placebo). Changes from baseline in HbA1c level HbA1c level over time 1.0 mg 2.0 mg 3.0 mg 4.5 mg Placebo Baseline 8.
Slide 7: HbA1c Targets Proportions
HbA1c Targets Proportions • The proportions of patients achieving targets of HbA1c <7.0%, ≤6.5%, and <5.7% at week 20 in the four doses group of HRS9531 were all higher than those in the placebo group. Proportion of patients achieving HbA1c targets
Slide 8: Body Weight Reduction
Body Weight Reduction • Body weight reductions from baseline to week 20 in four doses group of HRS9531 were all greater than the placebo group. Percentage changes from baseline in Percentage changes from baseline in body weight body weight over time 1.0 mg 2.0 mg 3.0 mg 4.5 mg Placebo Baseline 77.3
Slide 9: Other Efficacy Endpoints
Other Efficacy Endpoints • All doses of HRS9531 were superior to placebo at week 20 in the reductions of urinary albumin creatinine ratio (UACR), triglyceride (TG), and systolic blood pressure (SBP). Geometric percentage changes Geometric percentage changes from baseline in UACR from baseline in TG
Slide 10: Safety
Safety • Most adverse events (AEs) in HRS9531 groups were mild or moderate. • The most common treatment-related gastrointestinal AEs were diarrhea, nausea, and abdominal distension. • No clinically significant (<3 mmol/L) or severe hypoglycemia were reported. HRS9531 HRS9531 HRS9531 HRS9531 Placebo
Slide 11: Conclusions
Conclusions HRS9531 demonstrated superior glycemic and weight control, and other metabolic benefits compared to placebo in patients with T2DM at week 20. • HbA1c reduction Maximum LSMean change: HRS9531 (-2.7%) vs placebo (-0.3%); all one-sided p<0.0001 • Body weight reduction Maximum LSMean per
Slide 12: Acknowledgements
Acknowledgements • Patients and their families; • Investigators and research personnel from all study sites; • Staff at Jiangsu Hengrui Pharmaceuticals Co., Ltd. who participated in this trial.