The ENTRUST study

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG).

• IRAS ID

  1007556

• Contact name

  Jyoti Chauhan

• Contact email

  regulatory@89bio.com

• Sponsor organisation

  89bio, Inc

• Eudract number

  2023-503576-25

• Clinicaltrials.gov Identifier

  NCT05852431

• Research summary

  Pegozafermin is the “investigational” medicine being used and has not yet been approved for marketing by the Medicines and Healthcare products Regulatory Agency (MHRA). Pegozafermin belongs to a class of drugs known as FGF21 analogues. FGF21 is a hormone that is naturally present in the human body and actively works on the metabolism of fats and glucose in the liver, fat tissue, and pancreas. Pegozafermin has been modified so that it can last longer in the human body than the natural FGF21 form, therefore, affecting the metabolism for a longer duration of time. Prior studies have shown that pegozafermin has the ability to lower blood triglycerides, improve markers of glycaemic control and decrease abnormal fat storage in the liver.
  This study is a Randomised Double-Blind, Placebo-Controlled Phase 3 study that has been formulated to assess the efficacy, safety and tolerability of the therapeutic agent ‘Pegozafermin.’ Within this study, participants will be administered either pegozafermin at 20 mg, 30 mg, or placebo once weekly. This study is comprised of a 6-week screening period (including a 4-week lifestyle stabilisation period immediately followed by a 2-week TG qualification period), a 52-week double-blind treatment period as well as a 16-week safety follow-up period. After all remaining study participants have undergone 26 weeks of treatment, the primary analysis of the study will be initiated. Study participants may or may not benefit from their participation in this study. However, the results that are obtained from this study may benefit others in the future. 89bio, Inc. is the Sponsor that will be responsible for funding the research of this clinical study, with approximately 150 sites participating globally.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0664

• Date of REC Opinion

  6 Sep 2023

• REC opinion

  Further Information Favourable Opinion