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治験 NCT06152042（対象：1型糖尿病）は中止です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus 第II相・フェーズ2 37
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06152042 は 1型糖尿病 に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 中止 で、2023年12月28日 から開始しています。37 名の参加者 の募集が計画されています。この試験は Biomea Fusion Inc. によって主導され、2025年7月18日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月10日 です。
概要
Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.
詳細説明
Study COVALENT-112 is a 52-week, Phase 2 trial designed to examine beta-cell function, insulin sensitivity, and both glucose and lipid metabolism in participants with T1D treated with BMF-219. BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.
公式タイトル
Phase 2 Randomized, Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus
疾患名
1型糖尿病その他の研究識別子
- COVALENT-112
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
三重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Part 1 Part 1 uses a randomized, open-label design with parallel assignment between 2 treatment arms in each cohort. The Part 1 Eligible participants will be randomly assigned by cohort to 1 of 2 treatment arms:
* Cohort 1: Participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L
* Arm A: BMF-219 100 mg QD for 12 weeks
* Arm B: BMF-219 200 mg QD for 12 weeks
* Cohort 2: Participants with T1D ...もっと見る | BMF-219 BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. |
実験的Part 2 Part 2
Part 2 uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. Eligible participants will be randomly assigned to 1 of 3 arms using a 1:1:1 ratio:
* Arm A: BMF-219 100 mg QD for 12 weeks
* Arm B: BMF-219 200 mg QD for 12 weeks | BMF-219 BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. |
プラセボ対照薬Placebo Comparator Part 2 Study Double Blind Arm C matching placebo for 12 weeks. | BMF-219 BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To assess the effect on endogenous insulin secretion | Mean change from baseline in stimulated C-peptide AUC. | 26 Weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To assess the effect on endogenous insulin secretion | Maximum stimulated C-peptide: the highest value at any time point during the 4-hour MMTT. | 26 Weeks |
To assess the effect on additional glycemic parameters | Mean change from baseline in HbA1c. | 26 Weeks of treatment |
To assess the effect on additional glycemic parameters | Mean change from baseline in FPG. | 26 Weeks |
To assess hypoglycemia events | Percentage of participants with hypoglycemic episodes (with confirmed self-plasma glucose monitoring) including level 2 hypoglycemic events (\<54 mg/dL regardless of symptoms) and level 3 (severe) hypoglycemia across different timepoints. | 26 weeks |
To assess the effect on insulin doses | Change from baseline in mean daily insulin dosing. | 26 Weeks |
Rate of symptomatic hypoglycemic episodes | Evaluation and comparison of the number of symptomatic (both minor and severe) hypoglycemic episodes with BMF-219 vs placebo during the study. | 26 Weeks and during study duration |
Incidence of adverse events | Evaluation and comparison of the number of adverse events with BMF-219 vs placebo during the study. | 26 Weeks and during study duration |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
Males or females, age ≥18 and ≤70 years.
Diagnosed with stage 3 T1D within the following timeframes:
- Part 1 Cohort 1: Participants diagnosed within 3 years prior to screening.
- Part 1 Cohort 2: Participants diagnosed between 3 to 15 years prior to screening
- Part 2 : Participants diagnosed within 15 years prior to screening.
Treated with insulin only for at least 2 months prior to screening and proficient in the following in the opinion of the investigator:
- Counting carbohydrates
- Adjusting meal and correction boluses based on glucose readings with a stable insulin/carbohydrate ratio as well as correction factors
- Adjusting insulin and dietary therapy during special situations (eg, exercise, stress, intermittent diseases)
HbA1c ≥6.5 and ≤10.0% at screening.
Fasting or stimulated C-peptide Concentration at Screening as follows:
- C-peptide concentration ≥0.2 nmol/L if diagnosed within 3 years prior to screening.
- C-peptide concentration ≥0.08 nmol/L if diagnosed between 3 and 15 years prior to screening.
Documented history of at least 1 T1D1-related autoantibody.
If treated with lipid-lowering therapy, the dose must be stable for at least 30 days prior to screening.
Men and women of childbearing potential must use adequate birth control measures for the duration of the trial and at least 90 days after discontinuing study treatment.
Women who are not pregnant or lactating.
- Diagnosis of MODY, T2D or any other subtype of diabetes mellitus other than T1D.
- Have had recurrence (≥2 episodes) of severe hypoglycemia
- Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.
- Use of diabetes medications except insulin within 2 months prior to screening.
- Any significant cardiovascular disease or QTcF prolongation within the last 6 months prior to screening.
- Participants with fasting triglyceride ≥500 mg/dL.
- Have an eGFR <60 mL/min/1.73 m2 by the CKDEPI Creatinine Equation at screening.
- Impaired liver function, defined as screening AST or ALT >1.5 × ULN, Total bilirubin >1.5 × ULN with the exception of Gilbert's Syndrome.
- History of acute or chronic pancreatitis, complete pancreatectomy or pancreas transplants.
- Serum lipase and/or amylase above 1.5 x ULN.
- Known positive test for HIV, HBV surface antigen and COVID-19.
- Diagnosis of, or treatment for, any cancer within the last 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy.
- Active (symptomatic) celiac disease.
- History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs.
- History of cirrhosis.
- Currently participating in a formal weight loss program and/or are currently using any drugs for weight management within 2 months of screening.
- Use of Proton pump inhibitors (PPIs) is prohibited.
- Treatment with a moderate or strong CYP3A4 inhibitor, inducer, or substrate within a week prior to dosing on Day 1.
Biomea Fusion Inc.連絡先情報がありません。
11 2カ国の場所
Florida
Oceanic Research Group, North Miami Beach, Florida, 33169, United States
North Carolina
Lucas Research, Inc., Morehead City, North Carolina, 28577, United States
Oklahoma
Alliance for Multispecialty Research, LLC., Norman, Oklahoma, 73069, United States
Tennessee
University Diabetes & Endocrine Consultants, Chattanooga, Tennessee, 37411, United States
Texas
Velocity Clinical Research, Dallas, Texas, 75230, United States
Texas Diabetes & Endocrinology, Round Rock, Texas, 78681, United States
Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States
Virginia
Manassas Clinical Research Center, Manassas, Virginia, 20110, United States
British Columbia
Dr. T.G Elliott Inc. dba BC Diabetes, Vancouver, British Columbia, Canada
Ontario
Centricity Research, Toronto, Ontario, Canada