AZD6234 for Obesity with Weight-Related Comorbidities
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
Recruiting
Phase 3Interventional Study
Obesity or OverweightWeight-Related ComorbidityWith/Without Diabetes Mellitus, Type 2
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with obesity or overweight who have related health problems. Participants will take a medication called AZD6234 and will be compared to others taking a placebo over 68 weeks.
Are You a Good Fit for This Trial?
Must be takingIncretin-based medications
You may be able to join if
I am at least 18 years old.
I have a BMI of 30 or higher, or 27 or higher with weight-related health issues.
I have type 2 diabetes diagnosed at least 90 days ago, if applicable.
I have been managing my diabetes with diet and exercise or stable medications.
I have been taking my current weight management medication for at least 3 months.
My weight has been stable for at least 3 months.
I have tried to lose weight unsuccessfully at least once in my life.
You may not be able to join if
I have obesity caused by other endocrine disorders.
I have type 1 diabetes.
I have significant liver disease.
My liver enzymes are too high.
I have used insulin therapy for diabetes in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 f…
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
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