A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes

Early Phase 1

Recruiting

• Conditions: Obesity and Overweight
• Interventions: Drug: Placebo; Drug: HCR-188

• Registration Number: NCT06845943
• Lead Sponsor: Helicore Biopharma, Inc.

Brief 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).

Detailed Description

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Submitted: 2025-03-03
• Study Start: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts
HCR-188	HCR-188	Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	From the first dose and for up to 20 weeks	Percentage of participants with treatment-emergent adverse events
Treatment-emergent adverse events resulting in treatment discontinuation	From the first dose and for up to 20 weeks	Percentage of participants with treatment-emergent adverse events resulting in treatment discontinuation
Clinically significant laboratory values	From the first dose and for up to 20 weeks	Percentage of participants with clinically significant laboratory values, as assessed by laboratory-based adverse events
Clinically significant vital signs	From the first dose and for up to 20 weeks	Percentage of participants with clinically significant vital signs (blood pressure, heart rate, respiratory rate, temperature), as assessed by vital signs-related adverse events
QT interval on ECG	From the first dose and for up to 20 weeks	Percentage of participants with an increase from baseline in the QTcF by \> 60 milliseconds

Trial Locations

Locations (1)

Investigative Site; 🇦🇺 Herston, Queensland, Australia