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NCT03969719 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
164
Enrollment target

NCT03969719: Completed Phase 2 study, sponsored by Pfizer.

NCT03969719 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 164 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03969719, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
164 participants
Enrollment target

Study 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.

Primary Outcome

Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).

Interventions

  • DRUG Placebo
  • DRUG PF-06835919

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2019-07-18
Est. Completion 2021-03-30
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT03969719 record still lists

NCT03969719 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03969719 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03969719 about?

NCT03969719 is a clinical study titled "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". 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, ...

What is the current status of trial NCT03969719?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2019-07-18. Estimated completion is 2021-03-30.

What interventions are being tested in trial NCT03969719?

The interventions under investigation include: Placebo (DRUG), PF-06835919 (DRUG).

Who is sponsoring clinical trial NCT03969719?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03969719's enrollment target sits among peer trials

164 413th of 2000 higher than 1,583 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03969719, the US trial registry maintained by the National Library of Medicine. NCT03969719 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.