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RecruitingPhase 3

A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well AZD6234 works and how safe it is in adults with type 2 diabetes and excess weight or obesity. It compares AZD6234 with a placebo (a treatment with no active drug) by measuring the percent change in body weight after 68 weeks.

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older. All genders can join.
  • Have a BMI of 27 or higher. BMI is a measure of weight compared with height.
  • Were diagnosed with type 2 diabetes at least 90 days before screening.
  • Have an HbA1c of 6.0% to 10% at screening. This blood test measures average blood sugar. Manage diabetes with diet and exercise alone, or with a steady dose of an approved diabetes pill.
  • Have had no more than a 5% change in body weight for at least 3 months before being assigned to a study group.
  • Report at least one past attempt to lose weight that did not succeed.

Who can't join

  • Have obesity mainly caused by another hormone disorder.
  • Have type 1 diabetes or diabetes that is not clearly type 2.
  • Had ketoacidosis (dangerous acid buildup in the blood) or a severe high-blood-sugar state, with or without coma, within 3 months before screening.
  • Have serious liver or bile system disease, or certain high liver blood test results at screening: ALT or AST at least 3 times the upper normal limit, or total bilirubin more than 1.5 times that limit. The bilirubin rule does not apply to known Gilbert's syndrome.
  • Used a GLP-1 medicine, a type of medicine used for diabetes or weight loss, for any reason within 3 months before being assigned to a study group.
  • Used insulin for type 2 diabetes within 3 months before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Males \& females (inclusive of all gender identities) age ≥18 years * BMI ≥27 kg/m2 * Diagnosed with T2DM ≥90 days prior to Screening * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling) * Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation * History of at least one self-reported unsuccessful attempt to lose body weight in lifetime Exclusion Criteria: * Obesity primarily caused by other endocrine disorders * Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening * Significant hepatobiliary disease and/or any of the following results at Screening: * ALT ≥ 3.0 X ULN * AST ≥ 3.0 X ULN * TBL \> 1.5 X ULN (except for cases of known Gilbert's Syndrome) * Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation * Use of insulin therapy for T2DM within 3 months prior to screening

Study sites (54)

AL

AR

AZ

CA

FL

GA

IL

KS

LA

MA

MD

MI

MO

MS

NC

NE

NJ

OH

PA

TN

TX

VA