A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes
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).
Study details:
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in overweight or obese volunteers without type 2 diabetes mellitus. Up to 5 SAD cohorts and up to 5 MAD cohorts may be enrolled. Multiple dosing regimens are planned to be evaluated in the MAD portion of the study.
The duration of the study will be approximately 20 weeks per each participant completing the entire study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- EARLY_PHASE1
Study ID
NCT06845943
Intervention or treatment
DRUG: HCR-188
DRUG: Placebo
Conditions
- Obesity and Overweight
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Research sites nearby
Closest Location:
Investigative Site
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Investigative Site
Herston, Queensland, Australia
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Who is running the clinical trial?
Helicore Biopharma, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: HCR-188
| Drug: HCR-188 |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events | Percentage of participants with treatment-emergent adverse events | From the first dose and for up to 20 weeks |
| Treatment-emergent adverse events resulting in treatment discontinuation | Percentage of participants with treatment-emergent adverse events resulting in treatment discontinuation | From the first dose and for up to 20 weeks |
| Clinically significant laboratory values | Percentage of participants with clinically significant laboratory values, as assessed by laboratory-based adverse events | From the first dose and for up to 20 weeks |
| Clinically significant vital signs | Percentage of participants with clinically significant vital signs (blood pressure, heart rate, respiratory rate, temperature), as assessed by vital signs-related adverse events | From the first dose and for up to 20 weeks |
| QT interval on ECG | Percentage of participants with an increase from baseline in the QTcF by \> 60 milliseconds | From the first dose and for up to 20 weeks |
Secondary Outcome
References
Clinical Trials Gov: A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 DiabetesOther trials to consider
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