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

Status:	Recruiting
Conditions:	Gastrointestinal, Gastrointestinal, Diabetes, Diabetes
Therapuetic Areas:	Endocrinology, Gastroenterology
Healthy:	No
Age Range:	18 - 75
Updated:	3/30/2019
Start Date:	March 5, 2017
End Date:	June 7, 2019
Contact:	Reference Study ID Number: GC39547 www.roche.com/about_roche/roche_worldwide.htm
Email:	global-roche-genentech-trials@gene.com
Phone:	888-662-6728 (U.S. Only)

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

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.

Inclusion Criteria:

For T2DM Cohort only:

- Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2.

- A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening

- Current stable treatment (at least 3 months) for diabetes

- Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%.

- For women of childbearing potential, agreement to remain abstinent or use reliable
contraception during treatment period and for at least 42 days after last dose of
study drug

- For men, agreement to remain abstinent or use reliable contraception and agree to
refrain from donating sperm

- For NAFLD cohort only:

- BMI ≥ 25 kg/m2 and ≤ 40 kg/m2

- At screening, confirmed liver fat by ultrasound OR calculated Liver Fat ≥ 10% using
variables from the NAFLD liver fat score

- Hepatic steatosis on magnetic resonance imaging (MRI; ≥ 10% average liver proton
density fat fraction [PDFF]) prior to randomization.

Exclusion Criteria:

- Pregnant, lactating, or intending to become pregnant within 42 days after the last
dose of study drug is administered

- Suspected or confirmed diagnosis of Type 1 diabetes

- Significant cardiac disease

- Any psychiatric illness that increases the risk of participation in the study

- History of severe allergic, anaphylactic, or other hypersensitivity reactions, or
severe systemic bacterial, fungal, or parasitic infections

- Poor peripheral venous access

- Received blood products within 2 months before dosing

- Donation or loss of blood within 30-56 days prior to study drug administration

- Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or
human immunodeficiency virus (HIV) antibody

- Liver enzymes greater than acceptable limits

- History of eating disorders or surgical procedures for weight loss

- Active participation in a structured weight loss or dietary program

- Treatment with investigational therapy or exposure to any biological therapy

- Illicit drug use, marijuana use, or alcohol abuse

- Current use of more than one pack of cigarettes a day or equivalent nicotine-
containing products

- Any serious medical condition or abnormality in clinical laboratory tests

We found this trial at

sites

High Point Clinical Trials Center

High Point, North Carolina 27265

from

High Point, NC