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

NCT07784270
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,500
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Lead sponsor
AstraZeneca
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Start date
2026-08-20
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Number of sites
230
clinicaltrials.gov

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
clinicaltrials.gov
Acronym
SELENE 2
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Short title
A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight
clinicaltrials.gov
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-08-09
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First posted
2026-08-25
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Registry last updated
2026-10-28
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Primary completion date
2028-08-09
clinicaltrials.gov
Start date
2026-08-20
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Participants
1,500
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Participant count basis
Estimated
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Planned participants
1,500
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Protocol amendments
1
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Number of sites
230
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07784270
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07784270
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo in percent body weight change

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo on absolute change in weight

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5%

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10%

  4. Change in haemoglobin A1C from baseline at 68 weeks of treatment

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 on haemoglobin A1C change

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo on waist circumference change

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change

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

    Timeframe: 68 weeks

    To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change

  8. Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset

    Timeframe: 68 weeks

    Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • Research SiteFairhope, United StatesRecruiting
  • Research SiteHuntsville, United StatesNot yet recruiting
  • Research SiteMobile, United StatesNot yet recruiting
  • Research SiteMesa, United StatesNot yet recruiting
  • Research SitePhoenix, United StatesRecruiting
  • Research SiteTucson, United StatesNot yet recruiting
  • Research SiteLittle Rock, United StatesNot yet recruiting
  • Research SiteBakersfield, United StatesNot yet recruiting
  • Research SiteGardena, United StatesRecruiting
  • Research SiteLincoln, United StatesRecruiting
  • Research SiteTorrance, United StatesNot yet recruiting
  • Research SiteWalnut Creek, United StatesNot yet recruiting
  • Research SiteDoral, United StatesNot yet recruiting
  • Research SiteFleming Island, United StatesNot yet recruiting
  • Research SiteFort Lauderdale, United StatesNot yet recruiting
  • Research SiteOcoee, United StatesRecruiting
  • Research SiteWoodstock, United StatesRecruiting
  • Research SiteChicago, United StatesNot yet recruiting
  • Research SiteMelrose Park, United StatesNot yet recruiting
  • Research SiteOak Brook, United StatesNot yet recruiting
  • Research SiteAmes, United StatesNot yet recruiting
  • Research SiteLenexa, United StatesRecruiting
  • Research SiteNewton, United StatesNot yet recruiting
  • Research SiteMonroe, United StatesNot yet recruiting
  • Research SiteBeltsville, United StatesNot yet recruiting

And 205 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-524616-11
  • 159494
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)