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RecruitingPhase 3

A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus

A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)

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 for adults with obesity, or excess weight and a weight-related health problem, who do not have type 2 diabetes. It compares the percent change in body weight after 68 weeks with AZD6234 versus a placebo, which has no active study drug.

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 gender identities may join.
  • Have a BMI of 30 or higher, or a BMI of 27 or higher with at least one health problem listed below. BMI is a measure of weight compared with height.
  • For a BMI of 27 to under 30, have high blood pressure, unhealthy blood fat levels, breathing pauses during sleep, heart or blood vessel disease, heart failure, long-term kidney disease, fatty liver linked to metabolic problems, knee arthritis, or urine leaks when coughing or moving. The condition may be treated or untreated.
  • Your weight has changed by no more than 5% for at least 3 months before you are assigned to a study group.
  • Have tried to lose weight at least once in your life without success.

Who can't join

  • Your obesity is mainly caused by another hormone disorder.
  • Have a history of type 1 or type 2 diabetes, an HbA1c of 6.5% or higher (a blood test showing average blood sugar), or have used medicine to lower blood sugar within 3 months before screening.
  • Have a serious liver or bile-system disease, or certain high 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. These tests check for liver problems. The bilirubin limit does not apply to people with known Gilbert's syndrome.
  • Have used a GLP-1 medicine, or a medicine containing GLP-1, for any reason within 3 months before study group assignment. These medicines may be used for diabetes or weight loss.

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 ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence * 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 their lifetime Exclusion Criteria: * Obesity primarily caused by other endocrine disorders * History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening * Significant hepatobiliary disease and/or any of the following results at Screening: * ALT ≥ 3.0 × ULN * AST ≥ 3.0 × ULN * TBL \> 1.5 × 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.

Study sites (33)

AL

AZ

CA

FL

GA

IA

IL

MI

MO

MT

NC

ND

NJ

NV

NY

OH

OK

OR

PA

TN

TX

UT

VA

WA