NCT06833749

Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis

A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-336 As an Adjunct to Diet and Exercise in Obese Individuals with Osteoarthritis of the Knee

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: KeyBioscience AG · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if KBP-336 works to treat pain in osteoarthritis in individuals living with obesity. It will also learn about the effects on other parameters, such as quality of life and metabolism, as well as safety of KBP-336. The main questions it aims to answer are: * Does KBP-336 lower knee pain from osteoarthritis in individuals with obesity * Does KBP-336 lower bodyweight in the same population. Researchers will compare KBP-336 to a placebo (a look-alike substance that contains no drug) to see if KBP-336 works to pain and obesity Participants will: * Take KBP-336 or a placebo every week for 6 months * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and the amount of medication they use in addition to KBP-336

Conditions

• Osteoarthritis in the Knee
• Obesity

Interventions

Type	Name	Description
DRUG	KBP-336	KBP-336 is a long acting Dual Amylin and Calcitonin Receptor agonist designed for weekly administration through subcutaneous injection.
DRUG	Placebo	Placebo to match KBP-336

Timeline

• Start date: 2025-01-28
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

20 sites across 6 countries: Czechia, Denmark, Hong Kong, Moldova, Poland, Romania