Active — Not RecruitingPhase 3

VK2735 for Weight Management Phase 3

United States4,500 participantsStarted 2025-06-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years of age at the time of signing the informed consent
✓. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)

Exclusion criteria

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

What they're measuring

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

Timeframe: 78 Weeks

Trial details

NCT IDNCT07104500

SponsorViking Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-01

View on ClinicalTrials.gov More Weight Loss trials