RightFit
RecruitingPhase 3

A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)

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 when added to incretin-based medicines used for weight control. It is for adults with obesity, or excess weight and a weight-related health problem, with or without type 2 diabetes. Researchers will compare weight change with AZD6234 versus a placebo (no active drug) 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, of any gender.
  • BMI of 30 or higher, or BMI of 27 or higher with at least one listed weight-related health problem. BMI is a measure of weight compared to height.
  • For BMI of 27 to under 30, health problems may include high blood pressure, unhealthy blood fat levels, blocked breathing during sleep, heart or blood vessel disease, heart failure, long-term kidney disease, fatty liver linked to metabolism, knee arthritis, or urine leaks with coughing or activity.
  • If you have type 2 diabetes, it must have been diagnosed at least 90 days before screening.
  • If you have type 2 diabetes, your HbA1c (average blood sugar level) must be 6.0% to 9.0%. It must be managed with diet and exercise alone, or stable doses of oral blood sugar medicines and/or incretin-based medicines.
  • Taking a stable dose of an incretin-based medicine, at a dose enough for long-term weight control, for at least 3 months before screening and assignment to a study group.
  • Weight has changed by no more than 3% for at least 3 months before assignment to a study group.
  • Have tried to lose weight at least once without success.

Who can't join

  • Obesity mainly caused by another hormone disorder.
  • Type 1 diabetes.
  • Serious disease of the liver, gallbladder, or bile ducts.
  • Screening blood tests show liver enzymes ALT or AST at least 3 times the upper normal limit, or total bilirubin above 1.5 times the upper normal limit. The bilirubin rule has an exception for known Gilbert's syndrome.
  • 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 ≥ 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 * For participants with T2DM only: * Diagnosed with T2DM ≥ 90 days prior to Screening * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication * Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation. * Stable body weight (≤ 3% 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 * Type 1 diabetes mellitus * 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) * Use of insulin therapy for T2DM within 3 months prior to screening

Study sites (23)

CA

FL

GA

IL

MD

MO

NC

ND

NJ

NV

OH

OR

PA

TN

TX

VA

WA