A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Typ… (NCT06845943) | Clinical Trial Compass
SuspendedEarly Phase 1
A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes
Stopped: Business decision
Australia48 participantsStarted 2025-03-04
Plain-language summary
This is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of single and multiple doses of HCR-188 administered as subcutaneous injection(s).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body Mass Index (BMI) of 27 to 40 kg/m2, inclusive
* Except for overweight or obese, otherwise healthy as determined by the Investigator
* Stable body weight, defined as a \< 5 kg change during the 8 weeks prior to screening
* Females of childbearing potential must agree to use highly effective methods of contraception during the participation in the study
* Males must be surgically sterile, abstinent, or must agree to use highly effective methods of contraception during participation in the study
Exclusion Criteria:
* History of or active cardiovascular (CV) disease
* History of active pulmonary diseases
* History of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to Screening
* History of malignancy in the past 12 months or active malignancy
* History of bariatric surgery or use of gastric balloons
* History of diabetes mellitus Type 1 or 2
* History of chronic liver disease
* Pregnant or breastfeeding, or a positive pregnancy test at Screening
* Treatment with medications that may cause significant weight gain or weight loss
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-emergent adverse events
Timeframe: From the first dose and for up to 20 weeks
2
Treatment-emergent adverse events resulting in treatment discontinuation
Timeframe: From the first dose and for up to 20 weeks
3
Clinically significant laboratory values
Timeframe: From the first dose and for up to 20 weeks
4
Clinically significant vital signs
Timeframe: From the first dose and for up to 20 weeks
5
QT interval on ECG
Timeframe: From the first dose and for up to 20 weeks