NCT07011797

A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Corxel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study: * To evaluate the efficacy of different dose levels of CX11 tablets in body weight reduction as compared to placebo. * To compare the changes of effects in weight and weight-related indicators at the visit time points. * To evaluate the tolerability and safety of different doses of CX11 tablets in overweight/obese participants. * To assess the pharmacokinetics (PK) of different doses of CX11 tablets in overweight/obese participants. Overweight/obese participants who are successfully screened will be randomized in a 1:1:1:1:1 ratio to different doses of CX11 tablets or placebo. All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	CX11	CX11 tablets administered orally once daily (QD) with meals
OTHER	Placebo	Matching placebo tablets administered orally once daily (QD) with meals

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-03-23
• Completion: 2026-04-06
• First posted: 2025-06-10
• Last updated: 2025-08-14

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study