A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

• ClinicalTrials.gov Identifier: NCT03969719
• Recruitment Status: Recruiting
• First Posted: May 31, 2019
• Last Update Posted: February 10, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 28, 2019
• First Posted Date: May 31, 2019
• Last Update Posted Date: February 10, 2021
• Actual Study Start Date: July 18, 2019
• Estimated Primary Completion Date: March 3, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 28, 2019)

• Percent change from baseline in whole liver fat at Week 16 [ Time Frame: Baseline and Week 16 ]
• Change from baseline in glycosylated hemoglobin (HbA1c) at Week 16 [ Time Frame: Baseline and Week 16 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 28, 2019)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline through 28 days after last dose ]
• Number of Participants With Treatment Emergent Treatment-Related Hypoglycemia Adverse Events (HAEs) [ Time Frame: Baseline through 28 days after last dose ]
• Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline through follow-up visit ]
• Change from Baseline in Blood Pressure [ Time Frame: Baseline through follow-up visit ]
• Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline through follow-up visit ]
• Percent change from baseline in high-sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: Baseline through Week 16 ]
• Change from baseline in fasting insulin [ Time Frame: Baseline through Week 16 ]
• Change from baseline in fasting glucose [ Time Frame: Baseline through Week 16 ]
• Change from baseline in HOMA-IR [ Time Frame: Baseline through Week 16 ]
• Percent change from baseline in alanine aminotransferse (ALT) [ Time Frame: Baseline through Week 16 ]
• Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline through Week 14 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
• Official Title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN
• Brief Summary: This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Non-alcoholic Steatohepatitis

Intervention

• Drug: Placebo
  Placebo
• Drug: PF-06835919
  150 mg once daily
• Drug: PF-06835919
  300 mg once daily

Study Arms

• Placebo Comparator: Placebo
  Palacebo
  Intervention: Drug: Placebo
• Experimental: Low Dose
  150 mg
  Intervention: Drug: PF-06835919
• Experimental: High Dose
  300 mg
  Intervention: Drug: PF-06835919

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 28, 2019): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 7, 2021
• Estimated Primary Completion Date: March 3, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Males, or females of nonchildbearing potential
• 18 to 70 years of age
• Type 2 Diabetes Mellitus
• Liver fat >/=8% by MRI-PDFF
• On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion Criteria:

• History of other liver disease
• Unable to have an MRI performed
• Significant weight loss in the previous month and/or participant in current weight loss program
• History of diabetic complications with end-organ damage

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03969719
• Other Study ID Numbers: C1061011; DOSE RESPONSE IN PATIENTS ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2021