Apricus

• Research type

  Research Study

• Full title

  A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living with Obesity or Overweight with Comorbidity

• IRAS ID

  1010286

• Contact name

  Emmanuel Amadi

• Contact email

  emmanuel.amadi@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Research summary

  Background and Purpose: Researchers are looking for a better way to treat people with obesity or excess weight. People living with excess weight may be at a greater risk for serious problems such as high blood pressure, heart disease, or type 2 diabetes. When changes to diet and exercising aren’t enough for weight management, there may be a need for medical treatments.
  The trial drug AZD6234 is being developed to help people lose weight. AZD6234 is designed to work like a hormone called amylin that helps people feel full and eat less. In this trial, researchers want to learn how well AZD6234 helps people living with obesity lose weight compared to a placebo and how safe it is. A placebo looks like AZD6234 but does not contain any active medicine. AZD6234 and the placebo are given as an injection just under the skin.
  Design: This is a Phase 2, randomized, double-blind, placebo-controlled trial. Randomized means that a computer program will randomly assign the trial treatment each participant receives. Double-blind means none of the participants or study team will know what treatment each participant receives. Placebo-controlled means that some participants will receive a placebo.
  Population: This trial will include about 230 participants who are 18 to 75 years of age and have obesity or excess weight with at least 1 other medical problem related to having excess weight.
  Treatments and Procedures: Participants will be randomly assigned to take 1 of 3 different doses of either AZD6234 or placebo for 36 weeks (approximately 8 months). Participation will last about 11 months.
  To monitor the participants’ health throughout the trial, they will have:
  ► Blood and urine tests
  ► Physical exams
  ► Vital sign checks ► Heart function tests using an electrocardiogram (ECG)
  ► To report medications and any medical problems
  ► Questionnaires to complete

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  24/SC/0199

• Date of REC Opinion

  26 Sep 2024

• REC opinion

  Further Information Favourable Opinion