NCT06845943

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

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Helicore Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DRUG	HCR-188	Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
DRUG	Placebo	Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

Timeline

• Start date: 2025-03-04
• Primary completion: 2025-10-22
• Completion: 2027-12-01
• First posted: 2025-02-25
• Last updated: 2025-11-26

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study