Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR247799 · 1 trial · 1 indication
Absolute change from baseline in the % FMD index of the brachial artery
| Arm | Type | Description |
|---|---|---|
| SAR247799 | EXPERIMENTAL | SAR247799 repeated doses once daily in the morning under fasted condition for 28 days according to a sequential dose design |
| Placebo | PLACEBO_COMPARATOR | Identical matching placebo for SAR247799 and for sildenafil once daily in the morning under fasted condition for 28 days |
| Sildenafil | ACTIVE_COMPARATOR | Sildenafil once daily in the morning under fasted condition for 28 days |
| Name | Type | Description |
|---|---|---|
| SAR247799 | DRUG | Pharmaceutical form:Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form:Capsule Route of administration: Oral |
| Sildenafil | DRUG | Pharmaceutical form:Encapsulated tablet Route of administration: Oral |
| Acetylcholine | DRUG | Pharmaceutical form:Solution Route of administration: Transdermal |
Inclusion criteria : * Male and female stable Type 2 diabetes mellitus (T2DM) patients. * Body Mass Index between 18 and 35 kg/m\^2. * Stable T2DM patients, but otherwise healthy as assessed by a clinical and laboratory assessments and detailed medical history. * Diagnosis of T2DM for at least 6 mo...
SAR247799 is an investigational small molecule being developed for microvascular coronary artery disease. It was studied in a Phase 1 pharmacodynamic trial in patients with type 2 diabetes mellitus to assess its effects on endothelial function. The drug is not approved and remains in clinical development.
The specific molecular target of SAR247799 is not disclosed in the available information. The drug is a small molecule being evaluated for its effects on endothelial function in patients with type 2 diabetes mellitus and microvascular coronary artery disease. Its mechanism of action has not been publicly detailed.
SAR247799 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical research on this investigational small molecule for cardiovascular indications.
SAR247799 is in Phase 1 clinical development. A single Phase 1 trial has been completed, involving 54 participants. The drug is investigational and has not received regulatory approval for any use.
SAR247799 has one completed clinical trial registered as NCT03462017, titled 'Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus.' This Phase 1, randomized, double-blind, placebo-controlled study was conducted in Germany with 54 participants.
No, SAR247799 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug is still in clinical development and has not been authorized for marketing or patient use.