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

Not Applicable

Recruiting

• Conditions: Weight Loss
• Interventions: Drug: VK2735

• Registration Number: NCT07104383
• Lead Sponsor: Viking Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-23
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Status Verified: 2025-08
• Study First Posted: 2025-08-05
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-14
• Primary Completion: 2027-07-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Assignment	VK2735	VK2735 Placebo Comparator Once Weekly
Active Assignment (Dose #1)	VK2735	VK2735 7.5mg Once Weekly
Active Assignment (Dose #2)	VK2735	VK2735 12.5mg Once Weekly
Active Assignment (Dose #3)	VK2735	VK2735 17.5mg Once Weekly

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from baseline to Week 78 in body weight	78 Weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment	78 Weeks

Trial Locations

Locations (112)

Viking Clinical Site #2135; 🇺🇸 Scottsdale, Arizona, United States

Viking Clinical Site #2036; 🇺🇸 Little Rock, Arkansas, United States

Viking Clinical Site #2129; 🇺🇸 Lemon Grove, California, United States

Viking Clinical Site #2078; 🇺🇸 Manteca, California, United States

Viking Clinical Site #2132; 🇺🇸 Rolling Hills Estates, California, United States

Viking Clinical Site #2119; 🇺🇸 Denver, Colorado, United States

Viking Clinical Site #2121; 🇺🇸 Clearwater, Florida, United States

Viking Clinical Site #2060; 🇺🇸 Lakewood Ranch, Florida, United States

Viking Clinical Site #2062; 🇺🇸 Honolulu, Hawaii, United States

Viking Clinical Site #2038; 🇺🇸 Ypsilanti, Michigan, United States

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