Testing HCR-188 in overweight or obese healthy volunteers
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HCR-188 in Overweight or Obese Volunteers
This study is testing a new injection called HCR-188 to see if it's safe and how it affects overweight or obese people who don't have type 2 diabetes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Helicore Biopharma, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Herston, Queensland) |
| Trial ID | NCT06845943 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of HCR-188 administered via subcutaneous injections in overweight or obese volunteers without type 2 diabetes. The study is designed as a Phase 1, randomized, double-blind, placebo-controlled trial, involving both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Participants will be monitored over approximately 20 weeks to assess the effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese individuals with a BMI between 27 and 40 kg/m2 who are otherwise healthy.
Not a fit: Patients with a history of cardiovascular disease, diabetes, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for managing obesity and overweight conditions.
How similar studies have performed: While this approach is novel, similar studies targeting obesity have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Herston, Queensland
- Investigative Site — Herston, Queensland, Australia (Recruiting)
Study contacts
- Study coordinator: Helicore Clinical Operations
- Email: ct@helicore.com
- Phone: +1-650-468-0330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.