Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR425899 · 5 trials · 1 indication
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
Relative frequency of GI AEs
Absolute frequency of GI AEs
Change of glucagon receptor tracer binding in the liver with SAR425899 between Day 1 and Day 20
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg. |
| SAR425899 0.12 mg | EXPERIMENTAL | SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1). |
| SAR425899 0.16 mg | EXPERIMENTAL | SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2). |
| SAR425899 0.20 mg | EXPERIMENTAL | SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3). |
| Liraglutide | ACTIVE_COMPARATOR | Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2). |
| SAR425899 | EXPERIMENTAL | Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days |
| Cohort 1 | EXPERIMENTAL | Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine. |
| Cohort 2 | EXPERIMENTAL | Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation. |
| Cohort 3 | EXPERIMENTAL | Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation. |
| SAR425899 high dose | EXPERIMENTAL | Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 20 days |
| SAR425899 low dose | EXPERIMENTAL | Repeated once daily SC doses of SAR425899 administered over 20 days |
| SAR425899 (healthy subjects) | EXPERIMENTAL | Once daily SC doses of SAR425899 |
| Placebo (healthy subjects) | PLACEBO_COMPARATOR | Once daily SC doses of placebo |
| SAR425899 (T2DM Patients) | EXPERIMENTAL | Once daily SC doses of SAR425899 and two up titration steps in each dose cohort with metformin as background therapy |
| Placebo (T2DM Patients) | PLACEBO_COMPARATOR | Once daily SC doses of placebo and two up titration steps in each dose cohort with metformin as background therapy |
| Name | Type | Description |
|---|---|---|
| SAR425899 | DRUG | Self-administered by SC injection using a solution for injection in cartridge. |
| Placebo | DRUG | Self-administered by SC injection using a solution for injection in cartridge. |
| Liraglutide | DRUG | Self-administered by SC injection using a pre-filled pen. |
| Metformin | DRUG | Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose. |
| [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) | DRUG | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer) | DRUG | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
Inclusion criteria : * Participants with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit. * On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening. * Signed informed consent. ...
SAR425899 is an investigational small molecule developed for the treatment of Type 2 Diabetes Mellitus. It has been studied in overweight to obese adults with Type 2 Diabetes Mellitus, including patients not requiring anti-diabetic pharmacotherapy. All five of its clinical trials have been completed, and it remains in clinical development rather than approved for prescribing.
SAR425899 targets GCGR, the glucagon receptor, and acts as an agonist at that receptor. Its clinical program evaluated the drug in Type 2 Diabetes Mellitus, with trials also assessing energy expenditure in obese subjects and binding to the liver and pancreas in overweight to obese Type 2 Diabetes Mellitus patients.
SAR425899 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical program for the drug, which includes five completed trials in Type 2 Diabetes Mellitus and related metabolic study populations. No other developer is associated with the asset in its trial record.
SAR425899 has completed Phase 2 development. Its Phase 2 trial, NCT02973321, assessed safety and efficacy in 296 patients with Type 2 Diabetes Mellitus across the United States, Canada, Czechia, Germany, Hungary, Mexico, Russia, and Spain. The drug is investigational and has not been approved by the FDA.
SAR425899 has been studied in five completed trials. These include the Phase 2 study NCT02973321 in Type 2 Diabetes Mellitus, plus Phase 1 trials NCT03414736 on safety and tolerability, NCT03376802 on energy expenditure in obese subjects, and NCT03350191 on liver and pancreas binding. Total enrollment across the program was 469 participants.
SAR425899 trials were randomized, double-blind, and placebo-controlled, with 469 total participants enrolled across five completed studies. The Phase 2 trial NCT02973321 enrolled 296 patients with Type 2 Diabetes Mellitus, while the Phase 1 studies examined safety, tolerability, energy expenditure, and liver and pancreas binding in overweight to obese and Type 2 Diabetes Mellitus subjects.