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CX11

Phase 2

Obesity | Small molecule | Metabolic |Milestone Pharmaceuticals Inc.|Last Updated: Aug 14, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07011797A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese ParticipantsPHASE2 ACTIVE NOT_RECRUITING 250Jun 17, 2025Apr 6, 2026Aug 14, 202517 United States
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Study Endpoints
Primary Endpoints
Percentage change in body weight from baseline
At Week 26
Secondary Endpoints
Proportion of participants achieving ≥ 5% body weight reduction from baseline
At Week 26
Percentage change in body weight from baseline
At Week 36
Proportion of participants achieving ≥ 10% body weight reduction from baseline
At Week 26 and Week 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo groupPLACEBO_COMPARATOR -
120 mg groupEXPERIMENTAL -
160 mg groupEXPERIMENTAL -
200 mg fast titration groupEXPERIMENTAL -
200 mg slow titration groupEXPERIMENTAL -
Interventions
NameTypeDescription
CX11DRUGCX11 tablets administered orally once daily (QD) with meals
PlaceboOTHERMatching placebo tablets administered orally once daily (QD) with meals
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria Participants who meet all of the following criteria will be eligible to participate in this study: * Between 18 and 75 years old. Both men and women can participate, but women may make up to 70% of the participants. * BMI of 30 or higher, or a BMI between 27 and 30 with at least...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07011797studyFirstPostDate: changed