Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes (MARITIME-T2D-3)
A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
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：Amgen Call Center
- 電話番号：866-572-6436
- メール：medinfo@amgen.com
研究場所
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California
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San Diego、California、アメリカ、92120
- 募集
- Acclaim Clinical Research
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Florida
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Miami、Florida、アメリカ、33155
- 募集
- Bioclinical Research Alliance
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Miami Lakes、Florida、アメリカ、33016
- 募集
- Indago Research and Health Center
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Pompano Beach、Florida、アメリカ、33060
- 募集
- Clinical Research Center Of Florida
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Winter Park、Florida、アメリカ、32789
- 募集
- Conquest Research - Winter Park
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Virginia
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Arlington、Virginia、アメリカ、22205
- 募集
- Virginia Nephrology Group
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Washington
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Redmond、Washington、アメリカ、98052
- 募集
- Eastside Research Associates Health Research
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British Columbia
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Vancouver、British Columbia、カナダ、V5Y 3W2
- 募集
- Dr T G Elliott Incorporated - BC Diabetes
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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:
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening.
Exclusion Criteria:
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Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
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Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
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Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
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One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
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History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
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Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
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Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:
- liposuction and/or abdominoplasty that was performed > 1 year before screening.
- laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
他の名前：
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アクティブコンパレータ：Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
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 |
時間枠 |
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Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
時間枠：Baseline to Week 68
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Baseline to Week 68
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二次結果の測定
結果測定 |
時間枠 |
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Plasma Concentration of Maridebart Cafraglutide at Week 68
時間枠：Week 68
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Week 68
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Change from Baseline in HbA1c at week 68 [Superiority]
時間枠：Baseline to Week 68
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Baseline to Week 68
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Percent Change from Baseline in Body Weight at Week 68
時間枠：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving HbA1c < 7.0% at Week 68
時間枠：Week 68
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Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
時間枠：Week 68
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Week 68
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Percentage of Participants Achieving HbA1c < 5.7% at Week 68
時間枠：Week 68
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Week 68
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Change from Baseline in Fasting Plasma Glucose at Week 68
時間枠：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
時間枠：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
時間枠：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
時間枠：Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
時間枠：Baseline to Week 68
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Baseline to Week 68
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠：Up To 81 Weeks
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Up To 81 Weeks
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Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
時間枠：Up To 81 Weeks
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Up To 81 Weeks
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：MD、Amgen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 20230220
- 2025 (米国 NIH グラント/契約)
- 2025-523772-22-00 (Ctis)
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
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共有時間枠
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD 共有アクセス基準
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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。