*VISTA

• Research type

  Research Study

• Full title

  A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living with Obesity or Overweight with Comorbidity

• IRAS ID

  1010284

• Contact name

  Sadia Akhtar

• Contact email

  sadia.akhtar@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Clinicaltrials.gov Identifier

  NCT06579092

• Research summary

  Background: There is a class of medicines called glucagon-like peptide-1 (GLP-1) agonists that are approved to help reduce body weight and lower blood sugar levels in people with type 2 diabetes. These medicines are also approved to reduce weight in people living with obesity or overweight and a weight-related medical condition. Currently, these medications are mostly given as injections.
  The study drug, AZD5004, is a GLP-1 agonist in tablet form for once-a-day intake designed to help people with obesity or overweight and a weight-related medical condition the same way as the aforementioned injectable ones.
  Purpose: Different doses of AZD5004 are being evaluated to determine which dose(s) are the most effective at promoting weight loss and is also evaluating the safety of AZD5004.
  Design: This is a Phase 2, randomized, placebo-controlled, double-blind study.
  • Randomized means participants will be randomly assigned to a treatment group.
  • Placebo-controlled means that some participants will take a placebo. Placebos do not contain any active medicine.
  • Double-blind means that neither the participants nor the study staff know the treatment assigned to participant.
  Population: This study will include about 285 participants who are at least 18 years old and have a body mass index (BMI) of at least 30 OR a BMI of at least 27 with at least one weight-related medical condition.
  Treatments and Procedures: Participants will be randomly assigned to take 1 of 5 different doses of either AZD5004 or placebo for up to 36 weeks (8.5 months). Participation will last up to 10 months.
  To monitor the participants’ health throughout the study, they will have:
  • Blood and urine tests
  • Physical exams
  • Vital sign checks
  • Heart function tests using an electrocardiogram (ECG)
  • Questionnaires to complete
  • To report medications and any medical problems

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0183

• Date of REC Opinion

  30 Sep 2024

• REC opinion

  Further Information Favourable Opinion