Recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
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
ClinicalTrials.gov IDNCT07784725
PhasePHASE3
Enrollment2500
SponsorAstraZeneca
Age18 Years and older
SexALL
Conditions studied
Obesity or Overweight
About this study
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
Interventions
- Drug: AZD6234 — IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
- Drug: Placebo — Placebo matching IMP dose injected subcutaneously, once a week.
Primary outcomes
- Percent change in body weight from baseline at 68 weeks of treatment (68 weeks)
Eligibility information
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 locations
- Research Site, Dothan, Alabama 36305 United States
- Research Site, Huntsville, Alabama 35801 United States
- Research Site, Mesa, Arizona 85206 United States
- Research Site, Escondido, California 92025 United States
- Research Site, Clearwater, Florida 33765 United States
- Research Site, Jacksonville, Florida 32205 United States
- Research Site, Stockbridge, Georgia 30281 United States
- Research Site, Champaign, Illinois 61822 United States
- Research Site, Chicago, Illinois 60640 United States
- Research Site, Ames, Iowa 50010 United States
Showing 10 of 212 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.