Weight Loss
Conditions
Brief summary
This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight
Interventions
DRUGVK2735
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
Sponsors
Viking Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from baseline to Week 78 in body weight | 78 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment | 78 Weeks |
Countries
Puerto Rico, United States
Outcome results
None listed