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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 (SELENE 3)

2026年9月8日 更新者：AstraZeneca

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)

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

500

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100034
        • 尚未招聘
        • Research Site
      • Changchun、中国、130041
        • 尚未招聘
        • Research Site
      • Chengdu、中国、610072
        • 尚未招聘
        • Research Site
      • Chengdu、中国、611130
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510280
        • 尚未招聘
        • Research Site
      • Huzhou、中国、313003
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210008
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210009
        • 尚未招聘
        • Research Site
      • Ningbo、中国、315000
        • 尚未招聘
        • Research Site
  • 丹麦
      • Aarhus N、丹麦、8200
        • 尚未招聘
        • Research Site
      • Gandrup、丹麦、9362
        • 尚未招聘
        • Research Site
      • Herlev、丹麦、2730
        • 尚未招聘
        • Research Site
      • Herlev、丹麦、2730
        • 暂停
        • Research Site
      • Holbæk、丹麦、4300
        • 尚未招聘
        • Research Site
      • Hvidovre、丹麦、2650
        • 尚未招聘
        • Research Site
      • Middelfart、丹麦、5500
        • 尚未招聘
        • Research Site
      • Odense、丹麦、5000
        • 尚未招聘
        • Research Site
      • Vejle、丹麦、7100
        • 尚未招聘
        • Research Site
  • 以色列
      • Holon、以色列、5822012
        • 尚未招聘
        • Research Site
      • Jerusalem、以色列、91120
        • 尚未招聘
        • Research Site
      • Kfar Saba、以色列、4428164
        • 尚未招聘
        • Research Site
      • Petah Tikva、以色列、49100
        • 尚未招聘
        • Research Site
      • Petah Tikva、以色列、4937211
        • 尚未招聘
        • Research Site
      • Tel Aviv、以色列、64239
        • 尚未招聘
        • Research Site
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2V 4J2
        • 尚未招聘
        • Research Site
      • Calgary、Alberta、加拿大、T3R 1W9
        • 尚未招聘
        • Research Site
    • British Columbia
      • Surrey、British Columbia、加拿大、V3T 4G8
        • 招聘中
        • Research Site
      • Vancouver、British Columbia、加拿大、V5Y 3W2
        • 招聘中
        • Research Site
    • Ontario
      • Guelph、Ontario、加拿大、N1H 1B1
        • 招聘中
        • Research Site
      • Hamilton、Ontario、加拿大、L8L 5G8
        • 尚未招聘
        • Research Site
      • Stouffville、Ontario、加拿大、L4A1H2
        • 招聘中
        • Research Site
      • Toronto、Ontario、加拿大、M4G3E8
        • 撤销
        • Research Site
    • Quebec
      • Joliette、Quebec、加拿大、J6E 6A9
        • 尚未招聘
        • Research Site
      • Montreal、Quebec、加拿大、H4J 1E3
        • 招聘中
        • Research Site
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06100
        • 尚未招聘
        • Research Site
      • Ankara、土耳其（türkiye）、06800
        • 尚未招聘
        • Research Site
      • Antalya、土耳其（türkiye）、07059
        • 尚未招聘
        • Research Site
      • Center、土耳其（türkiye）、23200
        • 尚未招聘
        • Research Site
      • Istanbul、土耳其（türkiye）、34384
        • 尚未招聘
        • Research Site
  • 巴西
      • Belo Horizonte、巴西、30150-320
        • 尚未招聘
        • Research Site
      • Campinas、巴西、13060-080
        • 尚未招聘
        • Research Site
      • Campinas、巴西、13060-803
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、01236-030
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、04266-010
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、04039-002
        • 尚未招聘
        • Research Site
  • 日本
      • Chūōku、日本、103-0002
        • 尚未招聘
        • Research Site
      • Ichinomiya-shi、日本、491-8558
        • 尚未招聘
        • Research Site
      • Izunokuni-shi、日本、410-2295
        • 尚未招聘
        • Research Site
      • Kamakura-shi、日本、247-0056
        • 尚未招聘
        • Research Site
      • Kawagoe-shi、日本、350-0851
        • 尚未招聘
        • Research Site
      • Kitakyushu-shi、日本、802-0077
        • 尚未招聘
        • Research Site
      • Kyoto、日本、612-8555
        • 尚未招聘
        • Research Site
      • Kyoto、日本、607-8062
        • 尚未招聘
        • Research Site
      • Mito、日本、311-4153
        • 尚未招聘
        • Research Site
      • Nishinomiya-shi、日本、662-0971
        • 尚未招聘
        • Research Site
      • Yokohama、日本、230-8765
        • 尚未招聘
        • Research Site
      • Ōmihachiman、日本、523-0082
        • 尚未招聘
        • Research Site
  • 瑞典
      • Linköping、瑞典、58213
        • 暂停
        • Research Site
      • Lund、瑞典、222 22
        • 尚未招聘
        • Research Site
      • Mölndal、瑞典、43153
        • 尚未招聘
        • Research Site
      • Stockholm、瑞典、113 61
        • 尚未招聘
        • Research Site
      • Örebro、瑞典、703 62
        • 尚未招聘
        • Research Site
  • 美国
    • California
      • Escondido、California、美国、92025
        • 尚未招聘
        • Research Site
      • Lincoln、California、美国、95648
        • 招聘中
        • Research Site
      • Walnut Creek、California、美国、94598
        • 尚未招聘
        • Research Site
    • Florida
      • Fleming Island、Florida、美国、32003
        • 尚未招聘
        • Research Site
      • Jacksonville、Florida、美国、32205
        • 尚未招聘
        • Research Site
    • Georgia
      • Stockbridge、Georgia、美国、30281
        • 尚未招聘
        • Research Site
      • Woodstock、Georgia、美国、30189
        • 招聘中
        • Research Site
    • Illinois
      • Champaign、Illinois、美国、61822
        • 尚未招聘
        • Research Site
      • Chicago、Illinois、美国、60640
        • 尚未招聘
        • Research Site
    • Maryland
      • Beltsville、Maryland、美国、20705
        • 尚未招聘
        • Research Site
      • Oxon Hill、Maryland、美国、20745
        • 尚未招聘
        • Research Site
    • Missouri
      • Kansas City、Missouri、美国、64111
        • 尚未招聘
        • Research Site
    • Nevada
      • Las Vegas、Nevada、美国、89101
        • 尚未招聘
        • Research Site
    • New Jersey
      • Somerset、New Jersey、美国、08873
        • 尚未招聘
        • Research Site
    • North Carolina
      • Statesville、North Carolina、美国、28625
        • 尚未招聘
        • Research Site
    • North Dakota
      • Fargo、North Dakota、美国、58104
        • 招聘中
        • Research Site
    • Ohio
      • Columbus、Ohio、美国、43215
        • 尚未招聘
        • Research Site
    • Oregon
      • Portland、Oregon、美国、97202
        • 尚未招聘
        • Research Site
    • Pennsylvania
      • Smithfield、Pennsylvania、美国、15478
        • 尚未招聘
        • Research Site
    • Tennessee
      • Franklin、Tennessee、美国、37067
        • 撤销
        • Research Site
    • Texas
      • Houston、Texas、美国、77043
        • 尚未招聘
        • Research Site
    • Virginia
      • Manassas、Virginia、美国、20110
        • 尚未招聘
        • Research Site
    • Washington
      • Renton、Washington、美国、98057
        • 撤销
        • Research Site
  • 英国
      • Airdrie、英国、ML6 0JS
        • 尚未招聘
        • Research Site
      • Chippenham、英国、SN14 6GT
        • 尚未招聘
        • Research Site
      • Hull、英国、HU3 2PA
        • 招聘中
        • Research Site
      • Llandough、英国、CF64 2XX
        • 尚未招聘
        • Research Site
      • Rotherham、英国、S65 1DA
        • 尚未招聘
        • Research Site
  • 阿根廷
      • Buenos Aires、阿根廷、C1120AAC
        • 尚未招聘
        • Research Site
      • CABA、阿根廷、C1425HFA
        • 尚未招聘
        • Research Site
      • Ciudad de Buenos Aires、阿根廷、C1094AAD
        • 尚未招聘
        • Research Site
      • Ramos Mejía、阿根廷、B1704ETD
        • 尚未招聘
        • Research Site
      • Rosario、阿根廷、S2000PBJ
        • 尚未招聘
        • Research Site
      • San Nicolás、阿根廷、B2900DMH
        • 尚未招聘
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
匹配安慰剂
药品：Placebo
Placebo matching IMP dose injected subcutaneously, once a week.
实验性的：AZD6234
药品：AZD6234
IMP injected subcutaneously, once a week.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent change in body weight from baseline at 68 weeks of treatment
大体时间：68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change
68 weeks

次要结果测量

结果测量
措施说明
大体时间
Percent change in body weight from baseline at 68 weeks of treatment
大体时间：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
68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
大体时间：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
68 weeks
Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment
大体时间：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
68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
大体时间：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
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
大体时间：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
68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
大体时间：68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on triglycerides percent change
68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
大体时间：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
68 weeks
Change in HbA1c from baseline at 68 weeks of treatment
大体时间：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
68 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月24日

初级完成 (估计的)

2028年8月9日

研究完成 (估计的)

2028年8月9日

研究注册日期

首次提交

2026年8月10日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D8750C00011
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523295-23-00 (克蒂斯)
  • 159494 (注册表标识符：IND Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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