NCT03060538

A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease

A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Patients With Type 2 Diabetes Mellitus and Patients With Non-Alcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.

Conditions

• Diabetes Mellitus, Type 2
• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	BFKB8488A	Administered subcutaneously starting on Day 1 and according to dosing schedule.
OTHER	Placebo	Administered subcutaneously starting on Day 1 and according to dosing schedule.

Timeline

• Start date: 2017-03-05
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2017-02-23
• Last updated: 2020-03-27

Locations

18 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study