GLP1_NEW
Safiglipron (HRS-7535) 60 mg tablet once daily
SAFIGL_PO_60MG_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 -0.21 (-1.12 to 0.82) | 0.42 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.62 (-3.21 to 2.05) | 0.40 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.31 (0.00 to 11.85) | 0.53 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.70 (0.01 to 60.39) | 0.54 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -1.71 (-5.88 to 2.43) | 0.35 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -2.16 (-8.99 to 4.36) | 0.60 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 0.81 (0.36 to 1.82) | 0.58 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 2.30 (0.59 to 10.23) | 0.39 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 5.53 (2.90 to 10.82) | 0.22 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 15.12 (5.62 to 45.23) | 0.08 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 3.75 (1.91 to 7.87) | 0.17 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 1.37 (0.23 to 9.08) | 0.53 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 3.72 (0.57 to 32.76) | 0.33 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 1.34 (0.15 to 10.09) | 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