Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
iBio, Inc. · Industry
Who this trial is looking for
This trial is looking for overweight or obese adults aged 18 to 65. Participants will take the study drug IBIO-600 to help researchers understand its safety and effects on body composition.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have a BMI between 27.0 and 34.90.
My weight has been stable for the last 90 days.
I can walk without help from devices like crutches or a wheelchair.
I do not smoke or use nicotine products.
I am not pregnant or breastfeeding.
I agree to use contraception if I can become pregnant.
You may not be able to join if
I have a history of diabetes.
I have heart disease or significant heart issues.
I have any major muscle disease.
I have had significant laboratory test issues.
I have a history of cancer within the last 2 years.
I have been diagnosed with conditions that cause weak immune system.
I have a history of substance abuse in the past 5 years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 …
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).
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