A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight | NCT07784270 | Trialant

Not yet recruitingInterventionalPhase 3Updated Aug 25, 2026

A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

Overview

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

ClinicalTrials.gov ID: NCT07784270
Lead Sponsor: AstraZenecaINDUSTRY
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Phase 3
Enrollment: 1,500Estimated
Last Update Posted: Aug 25, 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 Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)
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, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Conditions

The medical conditions and diseases this study investigates.

Obesity or Overweight
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 ≥27 kg/m2

Diagnosed with T2DM ≥90 days prior to Screening

HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)

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 lifetime

Exclusion Criteria:

Obesity primarily caused by other endocrine disorders

Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening

Significant hepatobiliary disease and/or any of the following results at Screening:

ALT ≥ 3.0 X ULN

AST ≥ 3.0 X ULN

TBL > 1.5 X 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

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

Fairhope, Alabama 36532, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: AstraZenecaINDUSTRY

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