6-week Safety and PD Study in Adults With NAFLD

Browse trials for

• Liver Diseases 2,082
• Fatty Liver 1,449
• Non-alcoholic Fatty Liver Disease 1,472

Study arms

• Placebo comparator
  Placebo

  Drug: Placebo

• Experimental
  PF-06835919 Low Dose

  75 mg once daily

  Drug: PF-06835919 Low Dose

• Experimental
  PF-06835919 High Dose

  300 mg once daily

  Drug: PF-06835919 High Dose

Interventions

• DrugPlacebo

  0 mg

• DrugPF-06835919 Low Dose

  75 mg once daily

• DrugPF-06835919 High Dose

  300 mg once daily

Primary outcomes

1. Percent Change From Baseline in Whole Liver Fat at Week 6

   The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows: Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed). The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline. The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.

   Time frame: Baseline and Week 6

Secondary outcomes

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

   All-causality adverse events (AEs) were any untoward medical occurrence in a study participant who administered a product or medical device, the event need not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs were any untoward medical occurrence in a study participant who administered a product or medical device, the event needed to have a causal relationship with the treatment or usage. A TEAE was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.

   Time frame: Baseline up to Day 77 (28-35 days post last dose)

2. Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria

   The vital sign categorical criteria included: Sitting DBP (diastolic blood pressure) millimeter of mercury (mmHg) Change \>= 20 mmHg increase Sitting SBP (systolic blood pressure) (mmHg) Change \>= 30 mmHg increase Sitting DBP (mmHg) Change \>= 20 mmHg decrease Sitting SBP (mmHg) Change \>= 30 mmHg decrease Sitting DBP (mmHg) Value \< 50 mmHg Sitting Pulse Rate (bpm) Value \< 40 bpm or Value \> 120 bpm Sitting SBP (mmHg) Value \< 90 mmHg

   Time frame: Baseline up to Day 56 (Week 8)

3. Number of Participants With Post-dose ECG Data Meeting Categorical Criteria

   The ECG categorical criteria included: PR Interval (msec) percent (%)Change \>= 25% increase when baseline \>200 or \>=50% increase when baseline \<=200 QRS Interval (msec) %Change \>= 50% increase QTcF Interval (Fridericia's Correction) (msec) increase 30 \<= Change \< 60 or Change \>= 60 PR Interval (msec) Value \>= 300 QRS Interval (msec) Value \>= 140 QTcF Interval (Fridericia's Correction) (msec) 450 \<= Value \<480 or 480 \<=Value \<500 or Value \>= 500

   Time frame: Baseline up to Day 56 (Week 8)

4. Number of Participants With Laboratory Abnormalities

   Below parameters were evaluated for laboratory tests: Hemoglobin, Hematocrit, Erythrocytes, Ery. Mean Copuscular Volume, Ery. Mean Copuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration, Platelets, Leukocytes, Lymphocytes, Neuprophils, Basophils, Eosinophils, Monocytes, Bilirubin, Direct Biliirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Protein, Albumin, Albumin, Blood Urea Nitrogen, Creatinine, Urate, Sodium, Potassium, Chloride, Calcium, Bicarbonate, Glucose-Fasting, pH, Urine Glucose, Ketone, Urine Protein, Urine Hemoglobin, Urobilinogen, Urine Bilirubin, Nitrite, Leukocyte Esterase, Urine Erythocytes, Urine leukocytes, Hyaline Casts, Urine Creatinine.

   Time frame: Baseline up to Day 56 (Week 8)

Baseline characteristics

Publications

• Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27. PubMed 35590219 ↗

Related links

• To obtain contact information for a study center near you, click here. ↗

Study documents

• Study protocol · Jun 29, 2017
• Statistical analysis plan · Nov 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.