VK2735 for Weight Management Phase 3

Not Applicable

Recruiting

• Conditions: Weight Loss
• Interventions: Drug: VK2735

• Registration Number: NCT07104500
• 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 who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.

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: 4500

Inclusion Criteria

1. Age ≥18 years of age at the time of signing the informed consent

2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)

   • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
   • Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
   • BMI calculated at the Screening visit will be used to determine eligibility

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 (excluding 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, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
6. Treatment with glucose-lowering agent(s) within 90 days before screening
7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
8. History of acute or chronic pancreatitis

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
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment	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 (121)

Viking Clinical Site #1037; 🇺🇸 Birmingham, Alabama, United States

Viking Clinical Site #1128; 🇺🇸 Huntsville, Alabama, United States

Viking Clinical Site #1081; 🇺🇸 Mobile, Alabama, United States

Viking Clinical Site #1005; 🇺🇸 Chandler, Arizona, United States

Viking Clinical Site #1017; 🇺🇸 Flagstaff, Arizona, United States

Viking Clinical Site #1018; 🇺🇸 Peoria, Arizona, United States

Viking Clinical Site #1135; 🇺🇸 Scottsdale, Arizona, United States

Viking Clinical Site #1019; 🇺🇸 Tucson, Arizona, United States

Viking Clinical Site #1071; 🇺🇸 Chula Vista, California, United States

Viking Clinical Site #1070; 🇺🇸 Escondido, California, United States

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