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
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ClinicalTrials.gov Identifier: NCT03060538 |
Recruitment Status :
Completed
First Posted : February 23, 2017
Last Update Posted : March 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 Non-Alcoholic Fatty Liver Disease | Drug: BFKB8488A Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 5, 2017 |
Actual Primary Completion Date : | December 13, 2019 |
Actual Study Completion Date : | December 13, 2019 |

Arm | Intervention/treatment |
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Experimental: Multiple Ascending Dose BFKB8488A
Participants will be randomized to receive BFKB8488A. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort.
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Drug: BFKB8488A
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Other Name: RO7040551 |
Placebo Comparator: Placebo
Participants will receive BFKB8488A-matching placebo.
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Other: Placebo
Administered subcutaneously starting on Day 1 and according to dosing schedule. |
- Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to 18 weeks following first dose administration ]An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
- Serum BFKB8488A Concentration [ Time Frame: On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration) ]
- Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) [ Time Frame: On multiple days during treatment period and follow-up (up 18 weeks following first dose administration) ]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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060538

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT03060538 |
Other Study ID Numbers: |
GC39547 |
First Posted: | February 23, 2017 Key Record Dates |
Last Update Posted: | March 27, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Diabetes Mellitus Diabetes Mellitus, Type 2 |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Digestive System Diseases |