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Safiglipron (HRS-7535) tablet
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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 -0.30 (-1.31 to 0.72) | 0.56 |
| Type 2 diabetes (adults) | HbA1c change | weeks 20 to 36 (target week 26) | Placebo | MD -0.83 (-3.75 to 2.09) | 0.43 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.11 (0.00 to 4.02) | 0.64 |
| Type 2 diabetes (adults) | Level 2 or 3 hypoglycemia (participants) | longest follow-up | Placebo | HR 0.38 (0.00 to 27.60) | 0.65 |
| Type 2 diabetes (adults) | Systolic blood pressure change | weeks 20 to 36 (target week 26) | Placebo | MD -2.21 (-5.98 to 1.48) | 0.33 |
| Type 2 diabetes (adults) | Percent body weight change | weeks 20 to 40 (target week 26) | Placebo | MD -2.10 (-8.98 to 4.83) | 0.71 |
| Type 2 diabetes (adults) | Serious adverse events | longest follow-up | Placebo | HR 1.08 (0.54 to 2.18) | 0.45 |
| Type 2 diabetes (adults) | Discontinuation due to adverse events | longest follow-up | Placebo | HR 4.78 (1.17 to 28.92) | 0.17 |
| Type 2 diabetes (adults) | Nausea | longest follow-up | Placebo | HR 5.10 (2.35 to 11.44) | 0.18 |
| Type 2 diabetes (adults) | Vomiting | longest follow-up | Placebo | HR 17.44 (5.30 to 66.74) | 0.06 |
| Type 2 diabetes (adults) | Diarrhea | longest follow-up | Placebo | HR 4.28 (2.13 to 9.15) | 0.12 |
| Type 2 diabetes (adults) | Constipation | longest follow-up | Placebo | HR 2.69 (0.38 to 30.88) | 0.29 |
| Type 2 diabetes (adults) | Discontinuation due to gastrointestinal adverse events | longest follow-up | Placebo | HR 6.44 (0.72 to 119) | 0.20 |
| Type 2 diabetes (adults) | Acute pancreatitis | longest follow-up | Placebo | HR 0.92 (0.11 to 8.34) | 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