Study S003353

A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period

ClinicalTrials.gov record

Registration

Registration: NCT03414736
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 60
Start: 2018-01-19
Primary completion: 2018-10-05
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:SAR425899
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1205-1368

Registered primary outcomes

Frequency of gastrointestinal (GI) adverse events (AEs) [Main study: Up to week 8; Six-month study extension period: Up to month 8]
Frequency of GI AEs [Main study: Up to week 8; Six-month study extension period: Up to month 8]

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