*SOLSTICE

• Research type

  Research Study

• Full title

  A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus

• IRAS ID

  1010285

• Contact name

  Emmanuel Amadi

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-003527-14

• Clinicaltrials.gov Identifier

  NCT06579105

• Research summary

  Background: GLP-1 agonists are a class of medicines that are approved to help control hunger and lower blood sugar levels in people with obesity and type 2 diabetes. These medications are often given as injections.
  The study drug, AZD5004, is a GLP-1 agonist in tablet form designed to lower blood sugar levels and help people with type 2 diabetes lose weight. Taking daily tablets may be easier than injections for some people.
  Purpose: Different doses of AZD5004 are being evaluated to determine which dose(s) are the most effective at controlling HbA1c levels. The study is also evaluating the safety of AZD5004 and how the body responds to it.
  Design: This is a Phase 2, randomized, placebo-controlled, double-blind, and open-label study.
  • Randomized means participants will be randomly assigned by a computer program to a treatment group.
  • Placebo-controlled means that some participants will take a placebo. Placebos do not contain any active ingredients.
  • Double-blind means that neither the participants nor study staff know which treatment group the participant is in.
  Population: This study will include about 385 people who are at least 18 years old, have type 2 diabetes, and have blood sugar levels that are not well controlled with diet and exercise, metformin, or an SGLT2 inhibitor.
  Treatments and Procedures: Participants will be randomly assigned to take 1 of 5 different doses of AZD5004 or placebo. Participation will last up to 7 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/0184

• Date of REC Opinion

  30 Sep 2024

• REC opinion

  Further Information Favourable Opinion