NCT07652047

Brief Summary

A multi-center, randomized, placebo-controlled, double-blinded (within cohorts), Sponsor-unblinded, Phase 1b study to explore the safety, pharmacokinetics, and pharmacodynamics of CX11 tablets in participants with obesity or overweight with weight-related comorbidities.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
May 2026Jun 2027

Study Start

First participant enrolled

May 11, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 11, 2026

Last Update Submit

June 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage change in body weight from baseline

    Week 26

Study Arms (4)

Placebo group

PLACEBO COMPARATOR

Placebo

Other: Placebo

CX11 Group A

EXPERIMENTAL
Drug: CX11

CX11 Group B

EXPERIMENTAL
Drug: CX11

CX11 Group C

EXPERIMENTAL
Drug: CX11

Interventions

PlaceboOTHER

Matching placebo tablets administered orally once daily (QD) with meals

Placebo group
CX11DRUG

CX11 tablets administered orally once daily (QD) with meals

CX11 Group ACX11 Group BCX11 Group C

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, 18-55 years.
  • BMI ≥30.0 to ≤39.9 kg/m², or ≥27.0 to \<30.0 kg/m² with at least 1 weight-related comorbidity: prediabetes, hypertension, dyslipidemia, or obstructive sleep apnea.
  • Prior unsuccessful diet/exercise weight-loss attempt and stable body weight within 90 days.
  • Able to comply with study procedures and reproductive requirements.

You may not qualify if:

  • Diabetes or obesity due to endocrine/genetic causes.
  • Recent weight-loss drugs, GLP-1-based therapy, glucose-lowering drugs, obesity surgery/device, or investigational treatment.
  • Significant cardiovascular, ECG/QT, pancreatic, gallbladder, GI, liver, kidney, thyroid, psychiatric, malignant, infectious, autoimmune, or lab abnormality risks.
  • Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
  • Pregnancy, breastfeeding, recent nicotine/drug use, excessive alcohol use, or any condition/medication making participation inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Corxel Investigational site

Las Vegas, Nevada, 89113, United States

RECRUITING

Corxel Investigational Site

Austin, Texas, 78744, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start

May 11, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations