NCT07487376 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults
| NCT ID | NCT07487376 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | iBio, Inc. |
| Condition | Overweight , Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-05-24 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-05-24 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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. * 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. Exclusion Criteria: * 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. * 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).
Contact & Investigator
Cory Schwartz, PhD
STUDY DIRECTOR
iBio, Inc.
Frequently Asked Questions
Who can join the NCT07487376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Overweight , Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07487376 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07487376 currently recruiting?
Yes, NCT07487376 is actively recruiting participants. Contact the research team at IBIO-600-CT001@ibioinc.com for enrollment information.
Where is the NCT07487376 trial being conducted?
This trial is being conducted at Bayswater, Australia.
Who is sponsoring the NCT07487376 clinical trial?
NCT07487376 is sponsored by iBio, Inc.. The principal investigator is Cory Schwartz, PhD at iBio, Inc.. The trial plans to enroll 32 participants.
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