Overweight , ObesityPhase 1NCT07487376
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults
A Phase 1 study testing IBIO-600 in people with Overweight , Obesity, run by iBio, Inc. at 1 site in Australia.
Trial summary
The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- IBIO-600
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 24 May 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study
- Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity.
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- Be a nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization.
- Must not be pregnant or breastfeeding
- Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until study completion, or for a minimum of 9 months following the last dose of IP, whichever period is longer.
Who cannot join
- An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- History or active diagnosis of diabetes (Type 1 or 2).
- History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months).
- History or presence of clinically significant muscle disease
- History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.
- Clinically significant laboratory abnormalities that would preclude participation in the study.
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- History of malignancy, except for non-melanoma skin cancer excised > 2 years ago or cervical intraepithelial neoplasia successfully treated > 5 years prior to randomization.
- History or presence of any condition associated with significant immunosuppression.
- History of substance abuse or dependency, or recreational IV drug use within the past 5 years (self-reported).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Veritus Research
Bayswater, Victoria, 3153
Jess Parish, +61 415 909 945, jessparish@veritusresearch.com
About this study
Official title: A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adult Participants (IBIO-600-CT001).
The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.
Read the detailed description
The study is a single ascending dose study, with participants monitored for 9 months after administration.
This clinical trial will seek to address the following:
- Which dose of the study drug is most effective.
- How safe the study drug is and how well participants tolerate it.
- How much of the study drug can be found in blood (pharmacokinetics).
- How the study drug affects the body (pharmacodynamics).
- How the body's immune system responds to the study drug (immunogenicity).
- How the body's composition and physical function may change over the course of the study.
- Conditions
- Overweight , Obesity
- Being tested
- IBIO-600, Placebo
- Keywords
- iBio, Overweight, Obesity, Phase I, IBIO-600, Myostatin
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBIO-600Drug
IBIO-600 Subcutaneous injection
PlaceboDrug
Matching placebo; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBIO-600 (Cohort 1) | Experimental | Not described Receives: Drug: IBIO-600 |
| IBIO-600 (Cohort 2) | Experimental | Not described Receives: Drug: IBIO-600 |
| IBIO-600 (Cohort 3) | Experimental | Not described Receives: Drug: IBIO-600 |
| IBIO-600 (Cohort 4) | Experimental | Not described Receives: Drug: IBIO-600 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety and tolerability of a single dose of IBIO-600
Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs.
Measured: From Day 1 through Day 252 (end of study).
Secondary outcomes (10)
Pharmacokinetics of a single dose of IBIO-600
Maximum observed serum concentration (Cmax)
Measured: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time to maximum concentration (Tmax)
Measured: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Area under the curve (AUC)
Measured: Baseline to the last measurable concentration (AUC0-last)
Pharmacokinetics of a single dose of IBIO-600
AUC
Measured: Baseline to infinity (AUC0-inf)
Pharmacokinetics of a single dose if IBIO-600
t½: half-life
Measured: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Apparent total body clearance (CL/F)
Measured: Baseline through Week 36
Pharmacokinetics of a single dose of IBIO-600
Apparent volume of distribution (Vz/F)
Measured: Baseline up to Week 36
Pharmacodynamics (PD) of a single dose of IBIO-600
Change in circulating concentrations of total GDF8
Measured: Baseline through Week 36
Pharmacodynamics of a single dose of IBIO-600
Change in circulating concentrations of total GDF11
Measured: Baseline up to Week 36
Pharmacodynamics of a single dose of IBIO-600
Change in lipid panel tests
Measured: Baseline up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start24 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cory Schwartz, PhD, Study director, iBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487376
- Sponsor's protocol ID
- IBIO-600-CT001
- Status last verified
- May 2026
- First submitted
- 12 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adult Participants (IBIO-600-CT001).
- ClinicalTrials.gov ID
- NCT07487376
- Acronym / sponsor ID
- IBIO-600-CT001
- Conditions
- Overweight , Obesity
- Keywords
- iBio, Overweight, Obesity, Phase I, IBIO-600, Myostatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- iBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.
Detailed description
The study is a single ascending dose study, with participants monitored for 9 months after administration.
This clinical trial will seek to address the following:
- Which dose of the study drug is most effective.
- How safe the study drug is and how well participants tolerate it.
- How much of the study drug can be found in blood (pharmacokinetics).
- How the study drug affects the body (pharmacodynamics).
- How the body's immune system responds to the study drug (immunogenicity).
- How the body's composition and physical function may change over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBIO-600 (Cohort 1) | Experimental | Drug: IBIO-600 |
| IBIO-600 (Cohort 2) | Experimental | Drug: IBIO-600 |
| IBIO-600 (Cohort 3) | Experimental | Drug: IBIO-600 |
| IBIO-600 (Cohort 4) | Experimental | Drug: IBIO-600 |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 from any reconstructive and/or cosmetic surgery and/or non-invasive cosmetic procedure that may affect body weight during the study
Key exclusion criteria (9 listed)
- An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- History or active diagnosis of diabetes (Type 1 or 2).
- History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months).
- History or presence of clinically significant muscle disease
- History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBIO-600IBIO-600 Subcutaneous injection | Drug | IBIO-600 (Cohort 1), IBIO-600 (Cohort 2), IBIO-600 (Cohort 3), IBIO-600 (Cohort 4) |
| PlaceboMatching placebo; subcutaneous injection | Drug | Placebo |
Primary outcome
Assessment of the safety and tolerability of a single dose of IBIO-600
Time frame: 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.
10 secondary outcomes
Pharmacokinetics of a single dose of IBIO-600
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time frame: Baseline to the last measurable concentration (AUC0-last)
Pharmacokinetics of a single dose of IBIO-600
Time frame: Baseline to infinity (AUC0-inf)
Pharmacokinetics of a single dose if IBIO-600
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time frame: Baseline through Week 36
Pharmacokinetics of a single dose of IBIO-600
Time frame: Baseline up to Week 36
Pharmacodynamics (PD) of a single dose of IBIO-600
Time frame: Baseline through Week 36
Pharmacodynamics of a single dose of IBIO-600
Time frame: Baseline up to Week 36
Pharmacodynamics of a single dose of IBIO-600
Time frame: Baseline up to Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cory Schwartz, PhD study director
iBio, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBIO-600 in people with Overweight , Obesity, run by iBio, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cory Schwartz, PhD (979-446-0027, IBIO-600-CT001@ibioinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety and tolerability of a single dose of IBIO-600 (time frame: From Day 1 through Day 252 (end of study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.