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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060538
• Other study ID #: GC39547
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2017
• Est. completion date: December 13, 2019

Study information

• Verified date: March 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	inVentiv Health Clinical	Montreal	Quebec
United States	Pinnacle Research Group Cullman	Anniston	Alabama
United States	Pinnacle Research Group; Llc, Central	Anniston	Alabama
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Agile Clinical Research Trials	Atlanta	Georgia
United States	Hassman Research Institute	Berlin	New Jersey
United States	Southern California Research Center, Inc.	Coronado	California
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	MD Clinical	Hallandale Beach	Florida
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Premier Research Associate, Inc	Miami	Florida
United States	MidWest Clinical Research	Overland Park	Kansas
United States	Clinical Trials of Texas Incorporated	San Antonio	Texas
United States	Northeast Clinical Research of San Antonio LLC	San Antonio	Texas
United States	Consano Clinical Research	Shavano Park	Texas
United States	Carolina Research Center at Jones Family Practice	Shelby	North Carolina
United States	Stanford Health Care	Stanford	California
United States	Diabetes Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AE)	An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.	Up to 18 weeks following first dose administration
Secondary	Serum BFKB8488A Concentration		On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration)
Secondary	Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)	Participants are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and at least one post-baseline samples if above acceptable limits. The number and percentage of ATA-positive and ATA-negative participants will be summarized by treatment group.	On multiple days during treatment period and follow-up (up 18 weeks following first dose administration)