VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

Launched by VIKING THERAPEUTICS, INC. · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called VK2735 to see if it can help adults who have Type 2 Diabetes and are overweight or obese lose weight. The study will last about 78 weeks (about a year and a half) and will look at how well VK2735 works for weight loss, as well as how safe and tolerable it is. The trial is currently recruiting adults aged 18 and older who have a body mass index (BMI) of 27 or higher and have Type 2 Diabetes with blood sugar levels that are somewhat elevated but stable. People taking certain diabetes medications like GLP-1 receptor agonists or similar drugs are not eligible.

If you join the study, you will be randomly assigned to receive either VK2735 or a placebo (a pill with no active medicine), and neither you nor the study staff will know which one you are taking until the study ends. You will have regular check-ups over the course of the study to monitor your health, blood sugar, and weight. The goal is to find out if VK2735 can safely help with weight loss in people with Type 2 Diabetes, which may improve overall health. Some people will not be able to join if they have certain medical conditions or recent significant weight changes, so the study team will carefully review your health before enrolling.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years of age at the time of signing the informed consent
• • 2. Body mass index (BMI) ≥27 kg/m2
• • 3. 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
• Exclusion Criteria:
• • 1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
• • 2. Self-reported body weight change of 5% or more within 3 months of screening
• • 3. Have a prior or planned surgical treatment for obesity (except for liposuction or abdominoplasty if performed \>1 year prior to screening)
• • 4. 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)
• • 5. Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes mellitus (T2DM)
• • 6. 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
• • 7. 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
• • 8. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
• • 9. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• • 10. History of acute or chronic pancreatitis
• • 11. 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