Phase 2b Study of Efinopegdutide (MK-6024) in Adults with Precirrhotic Nonalcoholic Steatohepatitis

• Research type

  Research Study

• Full title

  A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

• IRAS ID

  1007627

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• ISRCTN Number

  -

• Clinicaltrials.gov Identifier

  -

• Research summary

  Nonalcoholic fatty liver disease (NAFLD) is a condition where excess fat builds up in the liver. NAFLD encompasses a spectrum of disease, including Nonalcoholic Steatohepatitis (NASH). Lifestyle changes such as weight loss and exercise are recommended; however, only a minority of patients achieve and sustain weight loss. Presently, there are no approved medications for the treatment of NASH, demonstrating a significant unmet medical need.
  This trial is testing Efinopegdutide compared to placebo in participants with precirrhotic NASH. Efinopegdutide is an experimental drug which hasn’t been approved for sale. The trial also includes an ‘open-label’ arm where participants receive Semaglutide (Wegovy™).
  About 300 participants of any gender aged between 18 to 80 years (inclusive), will take part in this trial.
  The duration of the trial will be approximately 70 weeks.
  There is a screening phase, lasting about 10 weeks, to see if patients can join the trial.
  Eligible participants will be randomly assigned to one of 5 treatment groups with once-weekly injections:
  • Group 1: 4 mg of Efinopegdutide
  • Group 2: 7 mg of Efinopegdutide
  • Group 3: 10 mg of Efinopegdutide
  • Group 4: Placebo
  • Group 5: 2.4 mg of Semaglutide
  The treatment will last up to 52 weeks with the participant visiting the trial site about 14 times. A follow up visit will occur 9 weeks after the last dose of study intervention, for adverse event monitoring.
  This trial will be performed at NHS sites in England and Scotland. The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  London - City & East Research Ethics Committee

• REC reference

  23/LO/0391

• Date of REC Opinion

  5 Sep 2023

• REC opinion

  Further Information Favourable Opinion