A Study to Evaluate the Safety and Tolerability of Differ... | NCT07652047

Studies
A Study to Evaluate the Safety and Tolerability of Different Doses of CX11 Tablets

NCT07652047

Sponsor

Corxel Pharmaceuticals

Status

Recruiting

Last Update Posted

Jun 17, 2026Actual

Enrollment

90Estimated

Phase

Phase 1

Conditions

Obesity & Overweight

Interventions

CX11
Placebo
CX11

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2026Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Jun 11, 2026

First Submission Date that Met QC Criteria

Jun 11, 2026

First Posted Date

Jun 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CX11	Drug	CX11 tablets administered orally once daily (QD) with meals	CX11 Group A CX11 Group B CX11 Group C

Measure	Description	Time Frame
Percentage change in body weight from baseline		Week 26

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study coordinator	Contact	201-268-3723		information.center@corxelbio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corxel Investigational site	Recruiting	Las Vegas	Nevada	89113	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided