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DA-302168S

Phase 3

Overweight and Obesity | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Jun 5, 2026

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 Enrollment840
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07629544A Study of DA-302168S in Participants With Overweight/ObesityPHASE3 NOT YET_RECRUITING 840 — — Jun 27, 2026Oct 19, 2027Jun 5, 20261 China
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Study Endpoints
Primary Endpoints
Percentage change from baseline in body weight
From baseline to week 40
The proportion of subjects with a body weight reduction ≥5% from baseline
From baseline to week 40
Secondary Endpoints
The proportion of subjects with a body weight reduction of ≥10% and ≥15%
From baseline to week 40
Percentage change from baseline in body weight
From baseline to week 52
The proportion of subjects with a body weight reduction ≥5%、10%、15% from baseline
From baseline to week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
High dose groupACTIVE_COMPARATORParticipants will receive DA-302168S orally once daily, starting with a dose of 2.5 mg and gradually titrated up to the target dose.
Low dose groupACTIVE_COMPARATORParticipants will receive DA-302168S orally once daily, starting with a dose of 2.5 mg and gradually titrated up to the target dose.
Placebo groupPLACEBO_COMPARATORParticipants will receive placebo tablets orally, once daily
Interventions
NameTypeDescription
DA-302168SDRUGA small molecule GLP-1R agonist tablet, orally administration, once daily
PlaceboDRUGMatching placebo tablet will be provided
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: 1. Age 18-75 years (inclusive), both males and females; 2. BMI requirements at screening: for obese participants, BMI ≥28 kg/m² with or without comorbidities; or for overweight participants, BMI ≥24.0 kg/m² and \<28 kg/m² with at least one of the following comorbidities: hyp...

Countries:China
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