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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06845943




Registration number
NCT06845943
Ethics application status
Date submitted
3/02/2025
Date registered
25/02/2025

Titles & IDs
Public title
A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes
Scientific title
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
Secondary ID [1] 0 0
HCR-188-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity and Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HCR-188
Treatment: Drugs - Placebo

Experimental: HCR-188 - Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts

Placebo comparator: Placebo - Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts


Treatment: Drugs: HCR-188
Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections

Treatment: Drugs: Placebo
Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-emergent adverse events
Timepoint [1] 0 0
From the first dose and for up to 20 weeks
Primary outcome [2] 0 0
Treatment-emergent adverse events resulting in treatment discontinuation
Timepoint [2] 0 0
From the first dose and for up to 20 weeks
Primary outcome [3] 0 0
Clinically significant laboratory values
Timepoint [3] 0 0
From the first dose and for up to 20 weeks
Primary outcome [4] 0 0
Clinically significant vital signs
Timepoint [4] 0 0
From the first dose and for up to 20 weeks
Primary outcome [5] 0 0
QT interval on ECG
Timepoint [5] 0 0
From the first dose and for up to 20 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigative Site - Herston
Recruitment postcode(s) [1] 0 0
- Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Helicore Biopharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Helicore Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+1-650-468-0330
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06845943