Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).
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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Arizona
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Gilbert、Arizona、アメリカ、85296
- 募集
- Gilbert Center for Family Medicine
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California
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Canoga Park、California、アメリカ、91304
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- San Fernando Valley Health Institute
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Cerritos、California、アメリカ、90703
- 募集
- Core Healthcare Group
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La Mesa、California、アメリカ、91942
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- Velocity Clinical Research Chula Vista
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Modesto、California、アメリカ、95355
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- Paradigm Clinical Research
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Pomona、California、アメリカ、91767
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- Empire Clinical Research
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Florida
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Miami、Florida、アメリカ、33135
- 募集
- Optimus U Corporation
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Miami、Florida、アメリカ、33015
- 募集
- San Marcus Research Clinic Inc
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Miami Lakes、Florida、アメリカ、33016
- 募集
- Indago Research and Health Center
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Orlando、Florida、アメリカ、32825
- 募集
- Florida Institute for Clinical Research
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Weston、Florida、アメリカ、33331
- 募集
- Encore Medical Research of Weston LLC
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Winter Park、Florida、アメリカ、32789
- 募集
- Conquest Research - Winter Park
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Illinois
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Skokie、Illinois、アメリカ、60077
- 募集
- Endeavor Health
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Iowa
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West Des Moines、Iowa、アメリカ、50266
- 募集
- Iowa Diabetes Research
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Kansas
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Lenexa、Kansas、アメリカ、66219
- 募集
- JCCT- Juno Northwest Houston
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Newton、Kansas、アメリカ、67114
- 募集
- Alliance for Multispecialty Research Newton
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Wichita、Kansas、アメリカ、67226
- 募集
- Alliance for Multispecialty Research LLC
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Louisiana
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Monroe、Louisiana、アメリカ、71201
- 募集
- Ima Clinical Research- Monroe
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Maryland
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Annapolis、Maryland、アメリカ、21401
- 募集
- Annapolis Internal Medicine, LLC
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Missouri
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Kansas City、Missouri、アメリカ、64114
- 募集
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas、Nevada、アメリカ、89148
- 募集
- Palm Research Center Inc
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New Jersey
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Trenton、New Jersey、アメリカ、08611
- 募集
- Premier Research
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North Carolina
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Morehead City、North Carolina、アメリカ、28557
- 募集
- West Clinical Research
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Ohio
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Cincinnati、Ohio、アメリカ、45242
- 募集
- Velocity Clinical Research - Cincinnati
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Cincinnati、Ohio、アメリカ、45246
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- Velocity Clinical Research - Springdale
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Rhode Island
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East Greenwich、Rhode Island、アメリカ、02818
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- Velocity Clinical Research - Providence
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Texas
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Austin、Texas、アメリカ、78704
- 募集
- Elligo Clinical Research Center
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Bellaire、Texas、アメリカ、77401
- 募集
- Johnson County Clinical Trials Juno Bellaire
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Corpus Christi、Texas、アメリカ、78414
- 募集
- Osvaldo A Brusco MD PA
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Denison、Texas、アメリカ、75020
- 募集
- Soma Clinical Trials, LLC
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Virginia
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Burke、Virginia、アメリカ、22015
- 募集
- Manassas Clinical Research Center Inc
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Birmingham、イギリス、B21 9RY
- 募集
- FutureMeds Birmingham
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Ontario
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Hamilton、Ontario、カナダ、L8L 5G4
- 募集
- Hamilton Medical Research Group
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San Juan、プエルトリコ、00909
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- Latin Clinical Trial Center
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Ehime
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Matsuyama、Ehime、日本、790-0034
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- Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
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Fukuoka
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Kitakyusyu-shi、Fukuoka、日本、807-0072
- 募集
- Morizono Medical Clinic
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Hiroshima
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Aki-gun、Hiroshima、日本、735-8585
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- Mazda Hospital of Mazda Motor Corporation
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Ibaraki
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Mito、Ibaraki、日本、310-0826
- 募集
- Nakamoto Medical Clinic
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Naka、Ibaraki、日本、311-0113
- 募集
- Nakakinen Clinic
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Tsuchiura-shi、Ibaraki、日本、300-0835
- 募集
- Ohishi Naika Clinic
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Kumamoto
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Kumamoto、Kumamoto、日本、860-0863
- 募集
- Morinaga Ueno Clinic
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Osaka
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Kashiwara-shi、Osaka、日本、582-0005
- 募集
- Shiraiwa Medical Clinic
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Shizuoka
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Shizuoka、Shizuoka、日本、424-0855
- 募集
- Suruga Clinic
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Tokyo
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Meguro-ku、Tokyo、日本、153-0053
- 募集
- Yutenji Medical Clinic
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Mitaka-shi、Tokyo、日本、181-0013
- 募集
- Medical Corporation Ouitsukai Kanno Naika
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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:
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Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
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Participants completing Study 20210184 must meet the following criteria:
- Completed the Week 72 visit in Study 20210184.
- Did not permanently discontinue the investigational product in the parent trial (20210184).
- Randomized within 7 days of week 72 visit in the parent trial.
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Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention.
Exclusion Criteria:
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Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity.
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Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m^2).
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Participant has known sensitivity to any of the products or components to be administered during dosing.
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History of ischemic optic neuropathy.
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Any malignancy diagnosed during the parent trial, except for the following treated with curative intent:
- Nonmelanoma skin cancers
- Breast ductal carcinoma in situ
- Cervical carcinoma in situ
- Prostate cancer in situ
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Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative[s]) history of medullary thyroid carcinoma (MTC).
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Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.
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Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the parent trial before randomization.
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Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
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History or evidence of any other clinically significant disorder, condition, disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
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Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
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Major surgical procedures planned during the trial.
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Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
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Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
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：ダブル
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 Low Dose Q4W
Participants who received low dose of maridebart cafraglutide in the parent trial (20210184 [NCT06858878]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W). |
Administered subcutaneously.
他の名前：
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実験的：Maridebart Cafraglutide Medium Dose Q4W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W. |
Administered subcutaneously.
他の名前：
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実験的：Maridebart Cafraglutide Medium dose Q8W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W). |
Administered subcutaneously.
他の名前：
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プラセボコンパレーター：Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
Administered subcutaneously. |
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実験的：Maridebart Cafraglutide High Dose Q4W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W. |
Administered subcutaneously.
他の名前：
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実験的：Maridebart Cafraglutide High Dose Q8W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W. |
Administered subcutaneously.
他の名前：
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プラセボコンパレーター：Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
Administered subcutaneously. |
|
実験的：Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)
Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses. |
Administered subcutaneously.
他の名前：
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実験的：Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)
Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W. |
Administered subcutaneously.
他の名前：
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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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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠：Baseline of current trial up to 60 weeks
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Baseline of current trial up to 60 weeks
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Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
時間枠：Baseline of parent trial (20210184) to Week 48 of current trial
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Baseline of parent trial (20210184) to Week 48 of current trial
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from Baseline of the Parent Trial in Waist Circumference
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percent Change from Baseline in Body Weight
時間枠：Baseline of current trial to Week 48
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Baseline of current trial to Week 48
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Percentage of Participants with No Body Weight Gain of >3% From Baseline
時間枠：Week 48 of current trial
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Week 48 of current trial
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Percentage of Participants with No Body Weight Gain of >5% From Baseline
時間枠：Week 48 of current trial
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Week 48 of current trial
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Percentage of Body Weight Reduction Maintained from the Parent Trial
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Change from Baseline of the Parent Trial in Hemoglobin A1c
時間枠：Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Change from Baseline in HbA1c
時間枠：Week 48 of current trial
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Week 48 of current trial
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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
その他の研究ID番号
- 20210182
- 2025-524788-19-00 (Ctis)
- U1111-1332-0531 (その他の識別子：WHO/UTN Number)
- 2025 (米国 NIH グラント/契約)
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。