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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

RecruitingPhase 3

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

Ages 18 and older · All sexes

Full 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

About the 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.

What is being tested

Sponsor: AstraZeneca · Participants: 500 · Started: Aug 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07776509

Locations in the U.S.

CaliforniaResearch Site, Escondido (Not yet recruiting)
Research Site, Lincoln
Research Site, Walnut Creek (Not yet recruiting)
FloridaResearch Site, Jacksonville (Not yet recruiting)
Research Site, Jacksonville (Not yet recruiting)
GeorgiaResearch Site, Stockbridge (Not yet recruiting)
Research Site, Woodstock
IllinoisResearch Site, Champaign (Not yet recruiting)
Research Site, Chicago (Not yet recruiting)
MarylandResearch Site, Beltsville (Not yet recruiting)
Research Site, Oxon Hill (Not yet recruiting)
MissouriResearch Site, Kansas City (Not yet recruiting)
NevadaResearch Site, Las Vegas (Not yet recruiting)
New JerseyResearch Site, Somerset (Not yet recruiting)
North CarolinaResearch Site, Statesville
North DakotaResearch Site, Fargo
OhioResearch Site, Columbus (Not yet recruiting)
OregonResearch Site, Portland (Not yet recruiting)
PennsylvaniaResearch Site, Smithfield (Not yet recruiting)
TexasResearch Site, Houston
VirginiaResearch Site, Manassas (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.