A study to see how well the body tolerates different dose levels of a new medicine for type 2 diabetes mellitus and non-alcoholic fatty liver disease called “BFKB8488A”.

A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus

Metabolic Disorder
Type 2 Diabetes Mellitus

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Basic Details

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT03060538, GC39547

This clinical trial was done to study a new medicine called, “BFKB8488A”, for the treatment of patients with type 2 diabetes mellitus (T2DM) or non-alcoholic fatty liver disease (NAFLD). This study was done to find out how safe BFKB8488A was for patients with T2DM and NAFLD when given at different doses. One hundred and fifty-three patients took part in this study at 17 study centers in USA.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT03060538, GC39547

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

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

Study 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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years & ≤ 75 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to see how well the body tolerates different dose levels of a new medicine for type 2 diabetes mellitus and non-alcoholic fatty liver disease called “BFKB8488A”.

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

Contact Genentech

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Find participating medical centers and current study status in each of them

A study to see how well the body tolerates different dose levels of a new medicine for type 2 diabetes mellitus and non-alcoholic fatty liver disease called “BFKB8488A”.

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com