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IBIO-600

Phase 1

Overweight , Obesity | Small molecule | Metabolic |iBio, Inc.|Last Updated: May 29, 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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07487376A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese AdultsPHASE1 RECRUITING 32May 24, 2026May 1, 2027May 29, 20261 Australia
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Study Endpoints
Primary Endpoints
Assessment of the safety and tolerability of a single dose of IBIO-600
From Day 1 through Day 252 (end of study).

Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs.

Secondary Endpoints
Pharmacokinetics of a single dose of IBIO-600
Baseline up to Week 36
Pharmacokinetics of a single dose if IBIO-600
Baseline up to Week 36
Pharmacodynamics (PD) of a single dose of IBIO-600
Baseline through Week 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IBIO-600 (Cohort 1)EXPERIMENTAL -
IBIO-600 (Cohort 2)EXPERIMENTAL -
IBIO-600 (Cohort 3)EXPERIMENTAL -
IBIO-600 (Cohort 4)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORMatching placebo
Interventions
NameTypeDescription
IBIO-600DRUGIBIO-600 Subcutaneous injection
PlaceboDRUGMatching placebo; subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Aged 18 to 65 years of age * In good general health, with no significant medical history * BMI between ≥ 27.0 and ≤ 34.90 kg/m2 * History of self-reported stable body weight (defined as change of no more or less than ± 5%) within 90 days of Screening. * Willingness to refrain ...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07487376Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 29, 2026NCT07487376Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 29, 2026NCT07487376Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07487376primaryCompletionDate: changed
LOWMay 24, 2026NCT07487376studyFirstPostDate: changed