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

Helicore Biopharma, Inc.

Status and phase: Suspended; Early Phase 1

Conditions: Obesity and Overweight

Treatments: Drug: HCR-188; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06845943

HCR-188-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

HCR-188

Experimental group

Description:

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

Treatment:

Drug: HCR-188

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo