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NCT Number: NCT07776509

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.

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Key information

Conditions

Obesity or Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight-Related Comorbidity With/Without Diabetes Mellitus, Type 2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, CABA, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6234

Drug

IMP injected subcutaneously, once a week.

Placebo

Drug

Placebo matching IMP dose injected subcutaneously, once a week.

Primary outcomes

  1. Percent change in body weight from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change

Secondary outcomes

  1. Percent change in body weight from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change in the T2DM and non-T2DM sub-populations separately

  2. Absolute change in weight (kg) from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the absolute change in weight in the full population and in the T2DM and non-T2DM sub-populations separately

  3. Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 5% in the full population and in the T2DM and non T2DM sub-populations separately

  4. Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 10% in the full population and in the T2DM and non T2DM sub-populations separately

  5. Change in waist circumference (cm) from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate whether AZD6234 as an adjunct to incretin-based therapies on the waist circumference in the full population and in the T2DM and non-T2DM sub-populations separately

  6. Percent change in triglycerides from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on triglycerides percent change

  7. Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the systolic blood pressure change

  8. Change in HbA1c from baseline at 68 weeks of treatment

    Time frame: 68 weeks

    For participants with T2DM only: to evaluate the effect of AZD6234 as an adjunct to incretin-based therapies on HbA1c change in the T2DM sub population only

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: SELENE 3

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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