Obesity & OverweightPhase 1NCT07890870
A Study to Evaluate a Single Dose of IBIO-610 in Participant With Obesity.
A Phase 1 study testing IBIO-610 in people with Obesity & Overweight, 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-610 has the right balance of safety, tolerability and impact on body composition in participants with obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- IBIO-610
- 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
- Dec 2026to Jan 2028
- 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 (inclusive) at the time of informed consent.
- In good general health, with no significant history and/or uncontrolled medical condition
- BMI between ≥ 30.0 and ≤ 45.0 kg/m2
- Able to fit in the DEXA and MRI scanners field of view in order to ensure adequate coverage and image acquisition.
- Must agree to refrain from any reconstructive and/or cosmetic surgery and/or noninvasive 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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- Nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization.
- Not pregnant or breastfeeding from the start of Screening until study completion.
- Woman of childbearing potential (WOCBP) or fertile man (see definitions in Section 5.3) who 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
- Underlying physical or psychological medical condition 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 of diabetes (Type 1 or 2), clinical evidence of diabetes (Hemoglobin A1C [HbA1c] ≥ 6.5%)
- History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months), or any documented blood glucose < 2.8 mmol/L within 1 year prior to randomization.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, or pancreatic injury, which is considered significant in the opinion of the Investigator.
- History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.
- History or presence of clinically significant skeletal muscle disease, including muscular dystrophy, inflammatory myopathy, or other clinically significant myopathy, or receipt of any procedure or treatment expected to materially affect skeletal muscle mass, regional body composition, or interpretation of study assessments within 6 months prior to randomization or planned from Screening through the end of study.
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- History of or active chronic kidney disease.
- History of major trauma or major surgery (i.e., surgeries that requires any type of anesthesia other than only local and/or topical) within 3 months prior to randomization or planned major surgery at any time during study participation
- Clinically significant laboratory abnormalities that would preclude participation in the study.
- History or presence of clinically significant liver disease,
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus (HIV)-1/2 antibody.
- History of malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, or other localized carcinoma in situ that has been definitively treated, with no evidence of recurrence and no requirement for ongoing anticancer therapy.
- Abnormal ECG findings at Screening
- History of substance abuse or dependency, or recreational IV drug use within the past 12 months.
- Pregnant or nursing (lactating) women.
- History or presence of clinically significant liver disease, including cirrhosis, hepatic decompensation, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or other acute or chronic liver disease that, in the opinion of the Investigator, could affect participant safety or the interpretation of study assessments.
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
Q-Pharm Pty Ltd
Brisbane, Queensland, 4006
Nucleus Network Brisbane
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-610 in Overweight or Obese Adult Participants.
The goal of this clinical trial is to learn which dose of study drug IBIO-610 has the right balance of safety, tolerability and impact on body composition in participants with obesity.
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
- Obesity & Overweight
- Being tested
- IBIO-610, Placebo
- Keywords
- iBio, Overweight, Obesity, IBIO-610, Phase I
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBIO-610Drug
IBIO-610; subcutaneous injection
PlaceboDrug
Matching placebo; subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBIO-610 (Cohort 1) | Experimental | Single Dose of IBIO-610; subcutaneous injection Receives: Drug: IBIO-610 |
| IBIO-610 (Cohort 2) | Experimental | Single Dose of IBIO-610; subcutaneous injection Receives: Drug: IBIO-610 |
| IBIO-610 (Cohort 3) | Experimental | Single Dose of IBIO-610; subcutaneous injection Receives: Drug: IBIO-610 |
| IBIO-610 (Cohort 4) | Experimental | Single Dose of IBIO-600; subcutaneous injection Receives: Drug: IBIO-610 |
| Placebo | Placebo comparator | Matching Placebo; subcutaneous injection 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-610; 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
Secondary outcomes (7)
Pharmacokinetics of a single dose of IBO-610
Time to maximum concentration (Tmax)
Measured: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Maximum observed serum concentration (Cmax)
Measured: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Area under the curve (AUC)
Measured: Baseline to last measurable concentration (AUCO-last) or up to Week 36.
Pharmacokinetics of a single dose of IBIO-610
AUC
Measured: Baseline to infinity (AUCO-inf) or up to Week 36
Pharmacokinetics of a single dose of IBIO-610
t1/2: half life
Measured: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Apparent total body clearance (CL/F)
Measured: Baseline through Week 36
Pharmacokinetics of a single dose of IBIO-610
Apparent volume of distribution (Vz/F)
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 posted22 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Molly Carr, MD, Study director, iBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890870
- Sponsor's protocol ID
- IBIO-610-CT001
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 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-610 in Overweight or Obese Adult Participants.
- ClinicalTrials.gov ID
- NCT07890870
- Acronym / sponsor ID
- IBIO-610-CT001
- Conditions
- Obesity & Overweight
- Keywords
- iBio, Overweight, Obesity, IBIO-610, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- iBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Oct 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-610 has the right balance of safety, tolerability and impact on body composition in participants with obesity.
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
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBIO-610 (Cohort 1) | Experimental | Drug: IBIO-610Single Dose of IBIO-610; subcutaneous injection |
| IBIO-610 (Cohort 2) | Experimental | Drug: IBIO-610Single Dose of IBIO-610; subcutaneous injection |
| IBIO-610 (Cohort 3) | Experimental | Drug: IBIO-610Single Dose of IBIO-610; subcutaneous injection |
| IBIO-610 (Cohort 4) | Experimental | Drug: IBIO-610Single Dose of IBIO-600; subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo; subcutaneous injection |
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 (inclusive) at the time of informed consent.
- In good general health, with no significant history and/or uncontrolled medical condition
- BMI between ≥ 30.0 and ≤ 45.0 kg/m2
- Able to fit in the DEXA and MRI scanners field of view in order to ensure adequate coverage and image acquisition.
- Must agree to refrain from any reconstructive and/or cosmetic surgery and/or noninvasive cosmetic procedure that may affect body weight during the study
Key exclusion criteria (16 listed)
- Underlying physical or psychological medical condition 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 of diabetes (Type 1 or 2), clinical evidence of diabetes (Hemoglobin A1C [HbA1c] ≥ 6.5%)
- History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months), or any documented blood glucose < 2.8 mmol/L within 1 year prior to randomization.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, or pancreatic injury, which is considered significant in the opinion of the Investigator.
- 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-610IBIO-610; subcutaneous injection | Drug | IBIO-610 (Cohort 1), IBIO-610 (Cohort 2), IBIO-610 (Cohort 3), IBIO-610 (Cohort 4) |
| PlaceboMatching placebo; subcutaneous injection | Drug | Placebo |
Primary outcome
Assessment of the safety and tolerability of a single dose of IBIO-610; Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs.
Time frame: From Day 1 through Day 252
7 secondary outcomes
Pharmacokinetics of a single dose of IBO-610
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Time frame: Baseline to last measurable concentration (AUCO-last) or up to Week 36.
Pharmacokinetics of a single dose of IBIO-610
Time frame: Baseline to infinity (AUCO-inf) or up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-610
Time frame: Baseline through Week 36
Pharmacokinetics of a single dose of IBIO-610
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 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Molly Carr, MD 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-610 in people with Obesity & Overweight, 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 16 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: opening soon, as of the sponsor's last update on 22 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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-610; Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs. (time frame: From Day 1 through Day 252). 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 22 Oct 2026.