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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2027-12-31

Brief Summary

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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).

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Detailed Description

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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

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Obesity and Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HCR-188

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

Group Type EXPERIMENTAL

HCR-188

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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HCR-188

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes