Recruiting
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
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 IDNCT07776509
PhasePHASE3
Enrollment500
SponsorAstraZeneca
Age18 Years and older
SexALL
Conditions studied
Obesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2
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: Lenbelintide — IMP injected subcutaneously, once a week.
- 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
* 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 locations
- Research Site, Escondido, California 92025 United States
- Research Site, Lincoln, California 95648 United States
- Research Site, Walnut Creek, California 94598 United States
- Research Site, Jacksonville, Florida 32204 United States
- Research Site, Jacksonville, Florida 32205 United States
- Research Site, Stockbridge, Georgia 30281 United States
- Research Site, Woodstock, Georgia 30189 United States
- Research Site, Champaign, Illinois 61822 United States
- Research Site, Chicago, Illinois 60640 United States
- Research Site, Beltsville, Maryland 20705 United States
Showing 10 of 96 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: 2026-11-10.