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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03060538 |
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Recruitment Status :
Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : November 28, 2019
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
| Estimated Primary Completion Date : | December 13, 2019 |
| Estimated Study Completion Date : | December 13, 2019 |
Resource links provided by the National Library of Medicine
| 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 |
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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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 |
Criteria
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
Information from the National Library of Medicine
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
Locations
| United States, Alabama | |
| Pinnacle Research Group Cullman | |
| Anniston, Alabama, United States, 36207 | |
| Pinnacle Research Group; Llc, Central | |
| Anniston, Alabama, United States, 36207 | |
| United States, California | |
| Southern California Research Center, Inc. | |
| Coronado, California, United States, 92118 | |
| Inland Empire Liver Foundation | |
| Rialto, California, United States, 92377 | |
| Stanford Health Care | |
| Stanford, California, United States, 94305 | |
| Diabetes Research Center | |
| Tustin, California, United States, 92780 | |
| United States, Florida | |
| MD Clinical | |
| Hallandale Beach, Florida, United States, 33009 | |
| Premier Research Associate, Inc | |
| Miami, Florida, United States, 33165 | |
| United States, Georgia | |
| Agile Clinical Research Trials | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Kansas | |
| MidWest Clinical Research | |
| Overland Park, Kansas, United States, 66209 | |
| United States, New Jersey | |
| Hassman Research Institute | |
| Berlin, New Jersey, United States, 08009 | |
| United States, North Carolina | |
| Carolina Research Center at Jones Family Practice | |
| Shelby, North Carolina, United States, 28150 | |
| United States, Tennessee | |
| New Orleans Center for Clinical Research | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| Texas Clinical Research Institute, LLC | |
| Arlington, Texas, United States, 76012 | |
| Dallas Diabetes & Endocrine Center | |
| Dallas, Texas, United States, 75230 | |
| Clinical Trials of Texas Incorporated | |
| San Antonio, Texas, United States, 78229 | |
| Northeast Clinical Research of San Antonio LLC | |
| San Antonio, Texas, United States, 78249 | |
| Consano Clinical Research | |
| Shavano Park, Texas, United States, 78231 | |
| Canada, Quebec | |
| inVentiv Health Clinical | |
| Montreal, Quebec, Canada, H3X 2H9 | |
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT03060538 History of Changes |
| Other Study ID Numbers: |
GC39547 |
| First Posted: | February 23, 2017 Key Record Dates |
| Last Update Posted: | November 28, 2019 |
| Last Verified: | November 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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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 |