Obesity and OverweightEarly Phase 1NCT06845943
A First-in-human Study of HCR-188 in Overweight or Obese Otherwise Healthy Volunteers Without Type 2 Diabetes
A Early Phase 1 study testing HCR-188 in people with Obesity and Overweight, run by Helicore Biopharma, Inc. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- HCR-188
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Mar 2025to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the 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
- Being tested
- HCR-188, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCR-188Drug
Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
PlaceboDrug
Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| HCR-188 | Experimental | Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts Receives: Drug: HCR-188 |
| Placebo | Placebo comparator | Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Percentage of participants with treatment-emergent adverse events
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the first dose and for up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start4 Mar 2025
- Primary completion22 Oct 2025
- Study completionDec 2027 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helicore Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845943
- Sponsor's protocol ID
- HCR-188-101
- Status last verified
- Nov 2025
- First submitted
- 3 Feb 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06845943
- Acronym / sponsor ID
- HCR-188-101
- Conditions
- Obesity and Overweight
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Business decision
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Helicore Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCR-188 | Experimental | Drug: HCR-188Single ascending dose (SAD) or multiple ascending dose (MAD) cohorts |
| Placebo | Placebo comparator | Drug: PlaceboSingle ascending dose (SAD) or multiple ascending dose (MAD) cohorts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCR-188Single (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections | Drug | HCR-188 |
| PlaceboSingle (SAD cohorts) or multiple (MAD cohorts) subcutaneous injections | Drug | Placebo |
Primary outcome
Treatment-emergent adverse events
Time frame: From the first dose and for up to 20 weeks
Percentage of participants with treatment-emergent adverse events
Treatment-emergent adverse events resulting in treatment discontinuation
Time frame: From the first dose and for up to 20 weeks
Percentage of participants with treatment-emergent adverse events resulting in treatment discontinuation
Clinically significant laboratory values
Time frame: From the first dose and for up to 20 weeks
Percentage of participants with clinically significant laboratory values, as assessed by laboratory-based adverse events
Clinically significant vital signs
Time frame: From the first dose and for up to 20 weeks
Percentage of participants with clinically significant vital signs (blood pressure, heart rate, respiratory rate, temperature), as assessed by vital signs-related adverse events
QT interval on ECG
Time frame: From the first dose and for up to 20 weeks
Percentage of participants with an increase from baseline in the QTcF by > 60 milliseconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HCR-188 in people with Obesity and Overweight, run by Helicore Biopharma, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: From the first dose and for up to 20 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.