Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02973321 | A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 296 | — | — | Dec 2, 2016 | Dec 27, 2017 | Mar 24, 2022 | 59 | United States, Canada +6 |
| NCT03376802 | A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects | PHASE1 | COMPLETED | 24 | — | — | Apr 18, 2018 | Dec 27, 2018 | Apr 25, 2022 | 2 | United States |
| NCT03414736 | A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period | PHASE1 | COMPLETED | 60 | — | — | Jan 19, 2018 | Oct 5, 2018 | Apr 25, 2022 | 3 | United States |
| NCT03350191 | A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients | PHASE1 | COMPLETED | 13 | — | — | Dec 20, 2017 | Jun 7, 2018 | Apr 25, 2022 | 1 | Sweden |
| NCT02411825 | Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients | PHASE1 | COMPLETED | 76 | — | — | Mar 1, 2015 | Jan 1, 2016 | Jun 15, 2018 | 1 | Germany |
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. ...