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Tests treatment safety and results for Overweight , Obesity
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults
ClinicalTrials.gov ID: NCT07487376
What this study is testing
What is IBIO-600?
IBIO-600 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight , obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to...
- 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...
- Clinically significant laboratory abnormalities that would preclude participation in the study.
See the full eligibility 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Bayswater, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayswater, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.