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IBIO-600

Phase 1

Overweight , Obesity | Small molecule | Metabolic |iBio, Inc.|Last Updated: May 29, 2026

Target and mechanism

Molecular targetmyostatin
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

IBIO-600 · 1 trial · 1 indication

Phase 1 1
NCT07487376A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese AdultsOverweight , Obesity
RECRUITING32 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults
Overweight , ObesityUnlock trial analytics

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 to 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

Frequently asked questions about IBIO-600

What is IBIO-600 used for?

IBIO-600 is an investigational small molecule being developed for the treatment of overweight and obesity. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in adults who are overweight or obese.

What does IBIO-600 target?

IBIO-600 targets myostatin, a protein that regulates muscle growth. By targeting myostatin, the drug may influence muscle mass and metabolism, which could be relevant for weight management. However, the exact mechanism of action in treating overweight and obesity is still under investigation in clinical trials.

Who is developing IBIO-600?

IBIO-600 is being developed by iBio, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol IBIO. The company is conducting clinical trials to evaluate the safety and efficacy of this drug candidate for overweight and obesity.

What phase is IBIO-600 in?

IBIO-600 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The ongoing Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose in overweight or obese adults.

What clinical trials is IBIO-600 in?

IBIO-600 is being evaluated in a Phase 1 clinical trial registered as NCT07487376. This study is recruiting participants in Australia and aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of IBIO-600 in overweight or obese adults. The trial is randomized, double-blind, and placebo-controlled, with an enrollment target of 32 participants.

Is IBIO-600 the same as any other drug?

No alternative names for IBIO-600 have been identified. It is a distinct investigational drug candidate developed by iBio, Inc. for the treatment of overweight and obesity. As it is still in early clinical development, it is not yet known by any other brand or generic name.