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

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 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 Overview

• Status: Suspended
• Conditions: Obesity and Overweight
• Intervention / Treatment: Drug: HCR-188; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCR-188; Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts	Drug: HCR-188; Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
Placebo Comparator: Placebo; Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts	Drug: Placebo; Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Helicore Biopharma, Inc.

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Actual): October 22, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HCR-188-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes