GLP1_NEW
Safiglipron (HRS-7535) 30 mg tablet once daily
SAFIGL_PO_30MG_QD
Effects across outcomes
Bayesian random effects estimate against the comparator of each analysis (usually placebo), posterior median and 95% credible interval. Green: clearly better; red: clearly worse.
| Condition | Outcome | Window | Versus | Effect (95% CrI) | SUCRA |
|---|---|---|---|---|---|
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Dapagliflozin | MD -0.29 (-1.18 to 0.71) | 0.52 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.65 (-3.16 to 1.98) | 0.40 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.31 (0.01 to 13.14) | 0.53 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.72 (0.01 to 55.24) | 0.53 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -1.02 (-5.16 to 3.26) | 0.25 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -0.64 (-7.58 to 6.28) | 0.36 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 1.63 (0.81 to 3.36) | 0.27 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 2.62 (0.68 to 11.35) | 0.36 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 2.78 (1.44 to 5.52) | 0.48 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 6.71 (2.46 to 21.03) | 0.23 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 2.92 (1.44 to 6.27) | 0.25 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 1.06 (0.17 to 7.36) | 0.60 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 2.32 (0.33 to 20.50) | 0.44 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 1.32 (0.15 to 11.10) | 0.37 |
Trials
- OUTSTAND-1A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (OUTSTAND-1)2024 · 284 randomized · 52 weeks
- NCT06589765A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)2024 · 810 randomized · 52 weeks
- NCT05759897A 16-week Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin2023 · 194 randomized · 16 weeks