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

NCT06845943 | Suspended Early Phase 1 DMC FDA Drug

• 1 other identifier: HCR-188-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

HCR-188

EXPERIMENTAL

Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts

Drug: HCR-188

Placebo

PLACEBO COMPARATOR

Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts

Drug: Placebo

Interventions

HCR-188 DRUG

Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

HCR-188

Placebo DRUG

Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helicore Biopharma, Inc.: lead

Study Sites (1)

Investigative Site

Herston, Queensland, Australia

Location

Related Links

• Sponsor's website

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 25, 2025
• Study Start: March 4, 2025
• Primary Completion: October 22, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)