治験レーダーAI | ||
|---|---|---|
治験 NCT07104383(対象:体重減少)は募集中です。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。 | ||
VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) 第III相・フェーズ3 1,100 無作為化 二重盲検 プラセボ対照
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants With Type 2 Diabetes Who Are Obese, or Overweight
- VK2735-302
| 参加グループ/群 | 介入/治療法 |
|---|---|
プラセボ対照薬Placebo Assignment VK2735 Placebo Comparator Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
実験的Active Assignment (Dose #1) VK2735 7.5mg Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
実験的Active Assignment (Dose #2) VK2735 12.5mg Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
実験的Active Assignment (Dose #3) VK2735 17.5mg Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percent change in body weight from baseline to Week 78 in body weight | 78 Weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment | 78 Weeks |
- Age ≥18 years of age at the time of signing the informed consent
- Body mass index (BMI) ≥27 kg/m2
- Have Type 2 Diabetes Mellitus according to the American Diabetes Association with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Type 2 diabetes mellitus may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling), EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists
History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
Self-reported body weight change of 5% or more within 3 months of screening
Have a prior or planned surgical treatment for obesity (except for liposuction or abdominoplasty if performed >1 year prior to screening)
Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes mellitus (T2DM)
Have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening
• Note: Severe hypoglycemia episodes should be considered when severe cognitive impairment requiring the assistance of another person occurs and the administration of carbohydrate, glucagon, or other resuscitative actions are required. Blood glucose (BG) measurements may not be available during such an event, but neurological recovery attributable to the restoration of BG to normal is considered sufficient evidence that the event was induced by a low BG concentration. If BG measurements are available, the levels associated with severe hypoglycemia are BG < 54 mg/dL
Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values > 270 mg/dL (on 2 non-consecutive days) within 4 weeks prior to randomization
Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
History of acute or chronic pancreatitis
Thyroid disease that is not controlled (Thyroid stimulating hormone (TSH) outside normal range by central lab at screening; one repetition during screening is allowed). Participants with previous history of partial/total thyroidectomy or hypothyroidism may be included, provided their hormone replacement dose has been stable for 3 months prior to screening
Alabama
Arizona
Arkansas
California
Colorado
District of Columbia
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maryland
Massachusetts
Michigan
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Rhode Island
South Carolina
Tennessee
Texas
Utah
Virginia
Washington