A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes (SELENE-Asia)
A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE-Asia)
This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
研究場所
-
-
-
Ansārinagar、インド、110 029
- Research Site
-
Calicut、インド、673008
- Research Site
-
Kolkata、インド、700014
- Research Site
-
Ludhiana、インド、141001
- Research Site
-
Meerut、インド、250005
- Research Site
-
Surat、インド、395002
- Research Site
-
-
-
-
-
Beijing、中国、100029
- Research Site
-
Bozhou、中国、236000
- Research Site
-
Cangzhou、中国、061002
- Research Site
-
Changzhou、中国、213004
- Research Site
-
Chongqing、中国、402260
- Research Site
-
Daqing、中国、163316
- Research Site
-
Ganzhou、中国、341099
- Research Site
-
Guangzhou、中国、510150
- Research Site
-
Guangzhou、中国、510800
- Research Site
-
Jiaxing、中国、314001
- Research Site
-
Jinan、中国、250031
- Research Site
-
Jinan、中国、250013
- Research Site
-
Liuzhou、中国、545005
- Research Site
-
Luoyang、中国、471003
- Research Site
-
Luzhou、中国、646000
- Research Site
-
Sanya、中国、572000
- Research Site
-
Shanghai、中国、200031
- Research Site
-
Shanghai、中国、310000
- Research Site
-
Shanghai、中国、201700
- Research Site
-
Shenyang、中国、110016
- Research Site
-
Shenyang、中国、110023
- Research Site
-
Shiyan、中国、442099
- Research Site
-
Suzhou、中国、215004
- Research Site
-
Wuhan、中国、430060
- Research Site
-
Xi'an、中国、710068
- Research Site
-
Xuancheng、中国、242000
- Research Site
-
Yuncheng、中国、044099
- Research Site
-
Zhengzhou、中国、450007
- Research Site
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 18 years or older at the time of signing informed consent.
- Body mass index:
- at least 28 kg/m²; or
- at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence.
- Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation.
- Participants with type 2 diabetes mellitus must:
- have been diagnosed at least 6 months before informed consent;
- have HbA1c between 6.0% and 10.0% at Screening; and
- be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening.
- At least one previous self-reported unsuccessful attempt to lose body weight.
- Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation.
- Able to provide signed informed consent.
Exclusion Criteria:
- Obesity primarily caused by another endocrine disorder.
- Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening.
- Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening.
- Clinically significant gastric-emptying abnormality requiring treatment.
- Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract.
- Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening.
- Previous or planned surgical treatment for obesity.
- Uncontrolled hypothyroidism or hyperthyroidism.
- Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin.
- Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol.
- Clinically important disease or disorder that may place the participant at risk or interfere with study participation.
- Known or suspected drug abuse or alcohol abuse.
- Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks.
- Weight-management treatment within 3 months before Randomisation.
- Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation.
- Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation.
- Use of insulin therapy for type 2 diabetes mellitus.
- Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants.
- Concomitant medication that may increase risk, affect study results, or interfere with study participation.
- Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher.
- History of psychosis or active symptomatic bipolar disorder.
- Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt.
- Participation in another clinical study within 30 days before Screening.
- Known hypersensitivity to AZD6234.
- Involvement in the planning and/or conduct of the study.
- Unlikely or unable to comply with study procedures, restrictions, or requirements.
- Previous randomisation in the present study.
- Currently pregnant or breastfeeding.
- Any other condition that, in the Investigator's judgement, makes participation inappropriate.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：AZD6234 Higher Target-Dose
Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period. |
administered once weekly. |
|
実験的：AZD6234 Lower Target-Dose
Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period. |
administered once weekly. |
|
プラセボコンパレーター：Placebo
Participants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period. |
Matching placebo administered once weekly. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent change in body weight from baseline at Week 64
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment. |
up to 64 weeks
|
|
Number of participants achieving at Least a 5% Reduction in Body Weight From Baseline at Week 64
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment. |
up to 64 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants achieving at Least a 10% Reduction in Body Weight From Baseline at Week 64
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 10% from baseline of treatment. |
up to 64 weeks
|
|
Change in waist circumference from baseline
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo in waist circumference change from baseline of treatment. |
up to 64 weeks
|
|
Absolute change in weight from baseline
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo on absolute change in weight from baseline of treatment. |
up to 64 weeks
|
|
Percent change in triglycerides from baseline
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo on triglycerides percent change from baseline of treatment. |
up to 64 weeks
|
|
Change in systolic BP from baseline
時間枠：up to 64 weeks
|
To evaluate the effect of AZD6234 as compared to placebo on systolic BP change from baseline of treatment. |
up to 64 weeks
|
|
Number of Participants With Adverse Events
時間枠：From first administration through Week 64 and the 4-week safety follow-up
|
Number of participants with prespecified adverse event categories. |
From first administration through Week 64 and the 4-week safety follow-up
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- D8750C00019
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。