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Not yet recruitingNCT07890870Updated Oct 22, 2026

A Study to Evaluate a Single Dose of IBIO-610 in Participant With Obesity.

A Phase 1 interventional study of IBIO-610 and Placebo in Obesity & Overweight, sponsored by iBio, Inc.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by iBio, Inc. · Phase 1, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Obesity & Overweight

Keywords

  • iBio
  • Overweight
  • Obesity
  • IBIO-610
  • Phase I
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 32 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

iBio, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 18 to 65 years (inclusive) at the time of informed consent.
  2. In good general health, with no significant history and/or uncontrolled medical condition
  3. BMI between ≥ 30.0 and ≤ 45.0 kg/m2
  4. Able to fit in the DEXA and MRI scanners field of view in order to ensure adequate coverage and image acquisition.
  5. Must agree to refrain from any reconstructive and/or cosmetic surgery and/or noninvasive cosmetic procedure that may affect body weight during the study
  6. Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity.
  7. Nonsmoker/nonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization.
  8. Not pregnant or breastfeeding from the start of Screening until study completion.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. History of diabetes (Type 1 or 2), clinical evidence of diabetes (Hemoglobin A1C [HbA1c] ≥ 6.5%)
  3. 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.
  4. History of acute or chronic pancreatitis, symptomatic gallbladder disease, or pancreatic injury, which is considered significant in the opinion of the Investigator.
  5. History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.
  6. 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.
  7. History of or active chronic kidney disease.
  8. 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
  9. Clinically significant laboratory abnormalities that would preclude participation in the study.
  10. History or presence of clinically significant liver disease,
  11. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus (HIV)-1/2 antibody.
  12. 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.
  13. Abnormal ECG findings at Screening
  14. History of substance abuse or dependency, or recreational IV drug use within the past 12 months.
  15. Pregnant or nursing (lactating) women.
  16. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    IBIO-610 (Cohort 1)

    Single Dose of IBIO-610; subcutaneous injection

    Drug: IBIO-610

  • Experimental
    IBIO-610 (Cohort 2)

    Single Dose of IBIO-610; subcutaneous injection

    Drug: IBIO-610

  • Experimental
    IBIO-610 (Cohort 3)

    Single Dose of IBIO-610; subcutaneous injection

    Drug: IBIO-610

  • Experimental
    IBIO-610 (Cohort 4)

    Single Dose of IBIO-600; subcutaneous injection

    Drug: IBIO-610

  • Placebo comparator
    Placebo

    Matching Placebo; subcutaneous injection

    Drug: Placebo

Interventions

  • DrugIBIO-610

    IBIO-610; subcutaneous injection

  • DrugPlacebo

    Matching placebo; subcutaneous injection

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetics of a single dose of IBO-610

    Time to maximum concentration (Tmax)

    Time frame: Baseline up to Week 36

  2. Pharmacokinetics of a single dose of IBIO-610

    Maximum observed serum concentration (Cmax)

    Time frame: Baseline up to Week 36

  3. Pharmacokinetics of a single dose of IBIO-610

    Area under the curve (AUC)

    Time frame: Baseline to last measurable concentration (AUCO-last) or up to Week 36.

  4. Pharmacokinetics of a single dose of IBIO-610

    AUC

    Time frame: Baseline to infinity (AUCO-inf) or up to Week 36

  5. Pharmacokinetics of a single dose of IBIO-610

    t1/2: half life

    Time frame: Baseline up to Week 36

  6. Pharmacokinetics of a single dose of IBIO-610

    Apparent total body clearance (CL/F)

    Time frame: Baseline through Week 36

  7. Pharmacokinetics of a single dose of IBIO-610

    Apparent volume of distribution (Vz/F)

    Time frame: Baseline up to Week 36

07

Study locations

1 site
  • Q-Pharm Pty Ltd
    Brisbane, Queensland 4006, Australia
    • Nucleus Network Brisbane · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890870
Lead sponsor
iBio, Inc.
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Molly Carr, MD
study director · iBio, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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