GLP1_NEW
Safiglipron (HRS-7535) 90 mg tablet once daily
SAFIGL_PO_90MG_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 -0.38 (-1.31 to 0.64) | 0.64 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.80 (-3.46 to 1.88) | 0.44 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.32 (0.00 to 12.42) | 0.53 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.70 (0.01 to 50.22) | 0.54 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -2.67 (-6.19 to 0.90) | 0.49 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -3.53 (-10.25 to 3.37) | 0.78 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 0.93 (0.43 to 2.07) | 0.52 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 3.72 (1.00 to 15.64) | 0.26 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 6.48 (3.49 to 12.59) | 0.17 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 17.14 (6.38 to 53.44) | 0.06 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 5.20 (2.66 to 10.66) | 0.09 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 2.06 (0.37 to 13.79) | 0.40 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 4.11 (0.68 to 37.29) | 0.30 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 0.45 (0.03 to 4.24) | 0.61 |
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