ObesityPhase 1NCT05310032

A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HSG4112 in High Doses

A Phase 1 study testing HSG4112 in people with Obesity, run by Glaceum at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

1. Study Objective i) To evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after single and multiple oral administration of high doses in healthy subjects. Read more about this study

Who is it for?: Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: HSG4112
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: 21 Apr 2022to 31 Mar 2023
Phase: 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 19 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
Adults between 19 and 50 years of age at screening.
Body mass index (BMI) between 18 and 24.9.
BMI (kg/m2) = Body weight (kg) / {Height (m)2}
In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
For Part 2 (i.e., the multiple dose study), female subjects who have regular menstrual cycles(28±7 days) and who are not pregnant or lactating.

Who cannot join

Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product.
Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice-containing drugs, aspirin, antibiotics).
One or more of the following laboratory test results at screening:
ALT (SGPT) > 60 IU/L
Glucose (fasting) > 110 mg/dL or < 70 mg/dL

Show all 24Show fewer

Systolic blood pressure of < 90 mmHg or > 150 mmHg, or diastolic blood pressure of < 60 mmHg or > 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.
History of drug/chemical abuse or tested positive in urine drug screen.
Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator.
Participation in any clinical study or bioequivalence study involving the administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
Smoker. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
Alcohol consumption of > 21 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period, starting from 3 days prior to dosing.
Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, or unable to abstain from ingesting such foods or beverages during the same period.
Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
Unable or unwilling to use acceptable contraceptive methods for themselves or their spouse/partner during the entire study period and up to 28 days after the last dosing and subjects who satisfy at least one of the pregnancy-related criteria below:
females of childbearing potential who plan to use hormonal contraceptives or oral contraceptives during the study period
females of childbearing potential confirmed "positive" in a pregnancy test
"females of childbearing potential" refer to females who have experienced menarche and have not undergone a successful surgical sterilization procedure (i.e., hysterectomy, bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy) or is not menopause (i.e., 12 months without menstruation).
Acceptable contraceptive methods include:
Use of an intrauterine device, which has been proven highly effective.
Physical contraception for subject or spouse/partner used with chemical sterilization (e.g., spermicide).
Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy).
Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label or Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect After Oral Administration of HSG4112 in Healthy Subjects

Study Objective
To evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after single and multiple oral administration of high doses in healthy subjects. ii) To evaluate the food effect on the pharmacokinetic characteristics of HSG4112 after a single oral administration of 1200 mg (6 tablets of HSG4112 200 mg) in healthy subjects.
Background The previous phase 1 clinical trials investigating HSG4112 included dosage only up to 720 mg of HSG4112 in both healthy and obese subjects. Since obese patients have various comorbidities, unexpected drug interactions may occur due to concomitant drugs. Securing a 2- to 5-fold safety margin is needed to tolerate this issue. Therefore, this study is designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effects of high-dose HSG4112 in healthy subjects.
Study Design and Plan

<Part 1> This study is a randomized, open-label, single dosing, phase 1 clinical study. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. Each subject will be randomized to one of the two dose groups. 8 subjects will receive 800 mg of HSG4112 with a high-fat meal, and 12 subjects will be randomized to 2 different sequential groups. Each subject will receive a single dose of HSG4112 1200 mg via oral administration with a high-fat meal and in fasted condition, with a washout period of 21 days in between each dosing. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.

<Part 2> This study is a randomized, double-blind, placebo-controlled, multiple dosing, phase 1 clinical study. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. Each subject will be randomized to one of the two dose groups (800 mg or 1200 mg of HSG4112). In each dose group, 6 subjects will be randomized to receive 800 mg of HSG4112, and 2 subjects will be randomized to receive placebo, both with a high-fat meal. The subjects will be studied in a double-blind manner and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration for 14 days. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead ECG, laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.

Conditions: Obesity
Being tested: HSG4112, Placebo
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HSG4112Drug
Also called 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol
Once-daily oral adminstration
PlaceboDrug
Once-daily oral adminstration

Study groups in NCT05310032
Study group	Role	What they receive
HSG4112 800 mg Single Dose	Experimental	Single oral dosing of HSG4112 800 mg Receives: Drug: HSG4112
HSG4112 1200 mg Single Dose	Experimental	Single oral dosing of HSG4112 1200 mg with a high-fat meal or fasting condition, with a washout period of 21 days in between each dosing Receives: Drug: HSG4112
HSG4112 800 mg Multiple Dose	Experimental	Multiple oral dosing of HSG4112 1200 mg for 14 days Receives: Drug: HSG4112
Placebo 800 mg Multiple Dose	Placebo comparator	Multiple oral dosing of placebo 800 mg for 14 days Receives: Drug: Placebo
HSG4112 1200 mg Multiple Dose	Experimental	Multiple oral dosing of HSG4112 1200 mg for 14 days Receives: Drug: HSG4112
Placebo 1200mg Multiple Dose	Placebo comparator	Multiple oral dosing of placebo 1200 mg for 14 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112
Maximum Plasma Concentration of HSG4112 (Cmax)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112 at Steady State
Maximum Plasma Concentration of HSG4112 at Steady State (Cmax,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Minimum Plasma Concentration of HSG4112 at Steady State
Minimum Plasma Concentration of HSG4112 at Steady State (Cmin,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Average Plasma Concentration of HSG4112 at Steady State
Average Plasma Concentration of HSG4112 at Steady State (Cavg,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity (AUCinf)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity at Steady State
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity at Steady State (AUCinf,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval (AUCtau)
Measured: Hour 0 to 24
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval at Steady State
Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval at Steady State (AUCtau,ss)
Measured: Hour 0 to 24
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point (AUClast)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point at Steady State
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point at Steady State (AUClast,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Half-Life of HSG4112
Half-life of HSG4112 (T1/2)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Half-Life of HSG4112 at Steady State
Half-life of HSG4112 at Steady State (T1/2,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
Time to Maximum Observed Plasma of HSG4112 (Tmax)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112 at Steady State
Time to Maximum Observed Plasma Concentration of HSG4112 at Steady State (Tmax,ss)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Oral Clearance of HSG4112
Oral Clearance of HSG4112 (CL/F)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Oral Clearance of HSG4112 at Steady State
Oral Clearance of HSG4112 at Steady State (CLss/F)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Volume of Distribution of HSG4112
Volume of Distribution of HSG4112 (Vd/F)
Measured: Hour 0 to 192
Pharmacokinetic Assessment by Volume of Distribution of HSG4112 at Steady State
Volume of Distribution of HSG4112 at Steady State (Vdss/F)
Measured: Hour 0 to 192
Safety and Tolerability Assessment by Adverse Event Monitoring
Number of participants with observed advese events
Measured: Day 1 to 9 following the last administration
Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
Number of participants with clinically significant change in vital signs including blood pressure (mmHg) measured with blood pressure monitor, heart rate (beats per minute) measured with pulse oximeter, and body temperature (degrees Celcius) measured with thermometer
Measured: Day 1 to 9 following the last administration
Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
Number of participants with clinically significant change in physical examination
Measured: Day 1 to 9 following the last administration
Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test
Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, and blood coagulation test
Measured: Day 1 to 9 following the last administration
Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram
Number of participants with clinically significant change in 12-lead electrocardiogram
Measured: Day 1 to 9 following the last administration

Secondary outcomes (5)

Pharmacodynamic Assessment by Change in Body Weight [Part 2]
Change in body weight
Measured: Days 1 to 17, Day 18, Day 20, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change in Waist Circumference [Part 2]
Change in waist circumference
Measured: Day 1, Day 8, Day 15, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change in Body Fat Mass [Part 2]
Change in body fat mass
Measured: Day 1, Day 8, Day 15, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change in Body Fat Percentage [Part 2]
Change in body fat percentage
Measured: Day 1, Day 8, Day 15, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change of Biomarkers [Part 2]
Measurement of biomarkers including leptin, adiponectin, insulin, C-peptide (connecting peptide), IL6 (interleukin 6), TNF-alpha (tumor necrosis factor alpha), and CCL2 (C-C motif ligand 2) from baseline to day of last dosing will be combined to assess the weight loss effect of HSG4112
Measured: Day 1 and 14 pre-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 202231 Mar 2023

First posted4 Apr 2022
Study start21 Apr 2022
Primary completion12 Dec 2022
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies 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: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05310032
Sponsor's protocol ID: HSG4112-P1-04
Status last verified: Mar 2022
First submitted: 25 Mar 2022
Last updated: 20 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label or Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect After Oral Administration of HSG4112 in Healthy Subjects
ClinicalTrials.gov ID: NCT05310032
Acronym / sponsor ID: HSG4112-P1-04
Conditions: Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GlaceumIndustry (pharma, biotech, devices)
Collaborators: Seoul National University Hospital
Study start: 21 Apr 2022 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 4 Apr 2022 (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.

Study Objective
To evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after single and multiple oral administration of high doses in healthy subjects. ii) To evaluate the food effect on the pharmacokinetic characteristics of HSG4112 after a single oral administration of 1200 mg (6 tablets of HSG4112 200 mg) in healthy subjects.
Background The previous phase 1 clinical trials investigating HSG4112 included dosage only up to 720 mg of HSG4112 in both healthy and obese subjects. Since obese patients have various comorbidities, unexpected drug interactions may occur due to concomitant drugs. Securing a 2- to 5-fold safety margin is needed to tolerate this issue. Therefore, this study is designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effects of high-dose HSG4112 in healthy subjects.
Study Design and Plan

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
HSG4112 800 mg Single Dose	Experimental	Drug: HSG4112Single oral dosing of HSG4112 800 mg
HSG4112 1200 mg Single Dose	Experimental	Drug: HSG4112Single oral dosing of HSG4112 1200 mg with a high-fat meal or fasting condition, with a washout period of 21 days in between each dosing
HSG4112 800 mg Multiple Dose	Experimental	Drug: HSG4112Multiple oral dosing of HSG4112 1200 mg for 14 days
Placebo 800 mg Multiple Dose	Placebo comparator	Drug: PlaceboMultiple oral dosing of placebo 800 mg for 14 days
HSG4112 1200 mg Multiple Dose	Experimental	Drug: HSG4112Multiple oral dosing of HSG4112 1200 mg for 14 days
Placebo 1200mg Multiple Dose	Placebo comparator	Drug: PlaceboMultiple oral dosing of placebo 1200 mg for 14 days

Who may qualify

Ages: 19 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
Adults between 19 and 50 years of age at screening.
Body mass index (BMI) between 18 and 24.9.
In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
For Part 2 (i.e., the multiple dose study), female subjects who have regular menstrual cycles(28±7 days) and who are not pregnant or lactating.

Key exclusion criteria (24 listed)

Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product.
Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice-containing drugs, aspirin, antibiotics).
One or more of the following laboratory test results at screening:
Systolic blood pressure of < 90 mmHg or > 150 mmHg, or diastolic blood pressure of < 60 mmHg or > 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.

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
HSG4112Also: 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenolOnce-daily oral adminstration	Drug	HSG4112 1200 mg Multiple Dose, HSG4112 1200 mg Single Dose, HSG4112 800 mg Multiple Dose, HSG4112 800 mg Single Dose
PlaceboOnce-daily oral adminstration	Drug	Placebo 1200mg Multiple Dose, Placebo 800 mg Multiple Dose

Primary outcome

Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112
Time frame: Hour 0 to 192
Maximum Plasma Concentration of HSG4112 (Cmax)
Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112 at Steady State
Time frame: Hour 0 to 192
Maximum Plasma Concentration of HSG4112 at Steady State (Cmax,ss)
Pharmacokinetic Assessment by Minimum Plasma Concentration of HSG4112 at Steady State
Time frame: Hour 0 to 192
Minimum Plasma Concentration of HSG4112 at Steady State (Cmin,ss)
Pharmacokinetic Assessment by Average Plasma Concentration of HSG4112 at Steady State
Time frame: Hour 0 to 192
Average Plasma Concentration of HSG4112 at Steady State (Cavg,ss)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity
Time frame: Hour 0 to 192
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity (AUCinf)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity at Steady State
Time frame: Hour 0 to 192
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity at Steady State (AUCinf,ss)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
Time frame: Hour 0 to 24
Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval (AUCtau)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval at Steady State
Time frame: Hour 0 to 24
Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval at Steady State (AUCtau,ss)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
Time frame: Hour 0 to 192
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point (AUClast)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point at Steady State
Time frame: Hour 0 to 192
Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point at Steady State (AUClast,ss)
Pharmacokinetic Assessment by Half-Life of HSG4112
Time frame: Hour 0 to 192
Half-life of HSG4112 (T1/2)
Pharmacokinetic Assessment by Half-Life of HSG4112 at Steady State
Time frame: Hour 0 to 192
Half-life of HSG4112 at Steady State (T1/2,ss)
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
Time frame: Hour 0 to 192
Time to Maximum Observed Plasma of HSG4112 (Tmax)
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112 at Steady State
Time frame: Hour 0 to 192
Time to Maximum Observed Plasma Concentration of HSG4112 at Steady State (Tmax,ss)
Pharmacokinetic Assessment by Oral Clearance of HSG4112
Time frame: Hour 0 to 192
Oral Clearance of HSG4112 (CL/F)
Pharmacokinetic Assessment by Oral Clearance of HSG4112 at Steady State
Time frame: Hour 0 to 192
Oral Clearance of HSG4112 at Steady State (CLss/F)
Pharmacokinetic Assessment by Volume of Distribution of HSG4112
Time frame: Hour 0 to 192
Volume of Distribution of HSG4112 (Vd/F)
Pharmacokinetic Assessment by Volume of Distribution of HSG4112 at Steady State
Time frame: Hour 0 to 192
Volume of Distribution of HSG4112 at Steady State (Vdss/F)
Safety and Tolerability Assessment by Adverse Event Monitoring
Time frame: Day 1 to 9 following the last administration
Number of participants with observed advese events
Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
Time frame: Day 1 to 9 following the last administration
Number of participants with clinically significant change in vital signs including blood pressure (mmHg) measured with blood pressure monitor, heart rate (beats per minute) measured with pulse oximeter, and body temperature (degrees Celcius) measured with thermometer
Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
Time frame: Day 1 to 9 following the last administration
Number of participants with clinically significant change in physical examination
Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test
Time frame: Day 1 to 9 following the last administration
Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, and blood coagulation test
Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram
Time frame: Day 1 to 9 following the last administration
Number of participants with clinically significant change in 12-lead electrocardiogram

5 secondary outcomes

Pharmacodynamic Assessment by Change in Body Weight [Part 2]
Time frame: Days 1 to 17, Day 18, Day 20, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change in Waist Circumference [Part 2]
Time frame: Day 1, Day 8, Day 15, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change in Body Fat Mass [Part 2]
Time frame: Day 1, Day 8, Day 15, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change in Body Fat Percentage [Part 2]
Time frame: Day 1, Day 8, Day 15, Day 22 post-dose before first meal
Pharmacodynamic Assessment by Change of Biomarkers [Part 2]
Time frame: Day 1 and 14 pre-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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.

Kyung Sang Yu, MD, PhD principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSG4112 in people with Obesity, run by Glaceum at 1 site in South Korea.

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 6 inclusion and 24 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: finished, as of the sponsor's last update on 20 Mar 2024. 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 South Korea. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112 (time frame: Hour 0 to 192). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05310032.

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 20 Mar 2024.