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VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) III期 1,100 随机化 双盲 安慰剂对照
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
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
安慰剂对照Placebo Assignment VK2735 Placebo Comparator Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
实验性Active Assignment (Dose #1) VK2735 7.5mg Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
实验性Active Assignment (Dose #2) VK2735 12.5mg Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
实验性Active Assignment (Dose #3) VK2735 17.5mg Once Weekly | VK2735 VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Percent change in body weight from baseline to Week 78 in body weight | 78 Weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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
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