A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With... | NCT07776509 | Trialant

Not yet recruitingInterventionalPhase 3Updated Aug 20, 2026

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)

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07776509
Lead Sponsor: AstraZenecaINDUSTRY
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Phase 3
Enrollment: 500Estimated
Last Update Posted: Aug 20, 2026Actual
Start Date: Aug 21, 2026Estimated
Primary Completion Date: Aug 9, 2028Estimated
Completion Date: Aug 9, 2028Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: 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)
Brief Summary: 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.
Detailed Description: This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM). Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively. Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.

Conditions

The medical conditions and diseases this study investigates.

Obesity or Overweight
Weight-Related Comorbidity
With/Without Diabetes Mellitus, Type 2

Interventions

The treatments and procedures being evaluated in this study.

AZD6234
Placebo

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts

The people to reach with questions about this study or how to join it.

AstraZeneca Clinical Study Information CenterContact

information.center@astrazeneca.com1-877-240-9479

Locations

Where the study is run and whether each site is currently recruiting.

Research Site

Escondido, California 92025, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: AstraZenecaINDUSTRY

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