A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
NCT07011797 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2025-08-14
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
Interventions
- DRUG
-
CX11
CX11 tablets administered orally once daily (QD) with meals
- OTHER
-
Placebo
Matching placebo tablets administered orally once daily (QD) with meals
Sponsors & Collaborators
-
Corxel Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-17
- Primary Completion
- 2026-03-23
- Completion
- 2026-04-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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