ObesityPhase 2NCT05197556
A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients
A Phase 2 study testing HSG4112 in people with Obesity, run by Glaceum at 1 site in South Korea.
Trial summary
1. Study Objective To assess the effect of HSG4112 on body weight To evaluate the safety and tolerability of HSG4112 2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of HSG4112 in healthy subjects through its Phase 1 trials, and is planning to perform… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- 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
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2022to 4 Apr 2023
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an informed consent form approved by the IRB before Screening.
- 19 to 70 years, inclusive, at Screening.
- BMI is 30 to 39.9 kg/m2, inclusive (obese), with or without comorbid conditions, or BMI is 27 to 29.9 kg/m2, inclusive (overweight), with at least 1 documented treated or untreated comorbid condition (e.g., hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea). All comorbid conditions must be considered by the Investigator to be clinically stable.
- ☞ (BMI (kg/m2) = Weight (kg) / {Height (m)2})
- Eligible females will be:
- females of childbearing potential who are not pregnant, evidenced by a negative serum hCG pregnancy test at Screening
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- non-lactating, or
- surgically sterile (defined as documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as at least 12 months prior to Screening without menses with no alternative explanation for the absence of menses).
- Eligible males should have no plans to have children up to 90 days following the last day of treatment.
- A history of at least 1 unsuccessful weight loss attempt, per Investigator judgment.
Who cannot join
- Clinically significant new illness, per Investigator judgment, in the 1 month before Screening and during the screening period.
- Significant history or clinical manifestation of allergic reaction or hypersensitivity to the investigational product or any related drug compound.
- Compliance with placebo self-administration is ≤80% during the 2-week single-blind placebo run-in period.
- Weight loss >3% during the 2-week single-blind placebo run-in period.
- Diabetes mellitus (type 1, type 2, or other). A remote history of gestational diabetes that has resolved is not exclusionary.
- Previous or planned (for the duration of the study) bariatric surgery or device (i.e., gastric bypass, gastric banding, sleeve gastrectomy, gastric balloon, biliopancreatic diversion)
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- Anticipated surgery during the study that may interfere with study completion or compliance with the protocol.
- Uncontrolled hypertension at Screening, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. Subjects with uncontrolled hypertension at Screening may be re-screened >3 months following initiation or adjustment of antihypertensive therapy, if enrollment has not been closed.
- Any of the following within 3 months of Screening: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, and cardiac arrhythmia requiring medical or surgical treatment.
- Evidence of any other unstable or untreated clinically significant hepatic, renal, neurological, immunological, respiratory, endocrine, hematological, cardiovascular, psychiatric, or neoplastic disease, or disease that, based on Investigator's judgment, will make the subject inappropriate for the study.
- Males with the following:
- history of, or known cause of hypogonadism (e.g., treatment for prostate cancer)
- history of infertility
- Klinefelter's syndrome or Kallmann's syndrome
- use of any medication within 6 months of Screening that can alter reproductive hormone levels, either as the intended effect or as a side effect, including: anabolic steroids, androstenedione, bicalutamide, cimetidine, dehydroepiandrosterone, diethylstilbestrol, other estrogens, dutasteride, finasteride, glucocorticoids (e.g., prednisone, cortisone, hydrocortisone, and decadron), oral ketoconazole, megestrol acetate, opiates (e.g., morphine, codeine, oxycodone, hydrocodone), spironolactone, testosterone or any androgen, and any medications for treating prostate cancer.
- Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of the Screening visit.
- Congestive heart failure New York Heart Association class III and IV.
- History of organ transplantation.
- Screening TSH greater than 2x upper limit of normal. Subjects on L-thyroxine replacement must be on a stable dose for at least 6 weeks prior to Screening.
- Hyperthyroidism (screening laboratory value TSH <lower limit of normal) and/or subjects taking methimazole, carbimazole, propylthiouracil, and/or beta-blockers for hyperthyroidism.
- Fasting triglycerides >500 mg/dL at Screening. Subjects with elevated triglycerides at Screening may be re-screened >3 months after initiation or adjustment of lipid-lowering treatment, if study enrollment has not been closed.
- Screening glycosylated hemoglobin (HbA1c) ≥6.5%.
- Fasting plasma glucose ≥126 mg/dL.
- Clinically significant abnormal hepatic (e.g., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome) or renal function laboratory tests (e.g., glomerular filtration rate <60 mL/min).
- Positive HBsAg, HCV Ab, HIV Ag/Ab, or VDRL at Screening.
- Malignancy within 5 years of the Screening visit (except adequately treated cutaneous basal cell or squamous cell carcinoma).
- All chronic medications (including but not limited to: antihypertensives, lipid-lowering drugs, cardiovascular drugs, antidepressants) must have been taken at a stable dose (and dosing interval) for at least 3 months prior to Screening.
- Treatment within 1 month of the Screening visit with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents) or St. John's Wort, or within 3 months with an approved anti-obesity drug.
- Recent (within 6 months of Screening) participation in any organized weight loss program (e.g., Juvis).
- Treatment within 3 months of the Screening visit with systemic (i.e., oral or intravenous) steroids for ≥7-day duration.
- Recent history (i.e., within 2 years prior to the Screening visit) of alcohol or drug abuse or a positive screen for drugs of abuse at Screening. Subjects with a positive drug screen may be eligible with approval from the Sponsor if the subject has a documented medical history requiring the need for chronic pain treatment and a documented concomitant medication resulting in a positive drug screen, and provided the subject is considered by the Investigator to be reliable to participate in the study.
- Significant change in smoking habits within 3 months prior to Screening, as judged by the Investigator.
- Participated in any other clinical study or bioequivalence study and was dosed with an investigaiontal product within 6 months prior to the first day of dosing, unless there is documentation that the subject received placebo.
- Significant change in diet or level of physical activity within 1 month prior to Screening, based on Investigator's judgment.
- Weight loss or gain of more than 5% within 3 months prior to the Screening visit by history or documented.
- Unwilling, or whose partner is unwilling, to use a medically acceptable means of contraception during and for 90 days following completion/withdrawal of the study.
- ☞ Medically acceptable contraceptive methods include:
- hormonal contraceptive
- intrauterine device that has been proven highly effective, used by the subject or the subject's spouse/partner
- physical contraception (male or female) used with chemical sterilization
- surgical sterilization of the subject or the subject's partner (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy).
- Subjects who, in the opinion of the Investigator, should not participate in in this study based on clinical laboratory test results or other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients Following 12 Weeks of Oral Treatment
- Study Objective
- To assess the effect of HSG4112 on body weight
- To evaluate the safety and tolerability of HSG4112
Read more
- Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of HSG4112 in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the safety and efficacy of HSG4112 in overweight and obese patients.
- Number of Subjects This study is a Phase 2a clinical trial designed to evaluate the safety and efficacy of HSG4112 following multiple-dose administration. The subject sample size estimate for the primary efficacy endpoint was based on total body weight, and assumes repeated measurement of body weight occurs at Baseline and every 4 weeks thereafter during the 12-week treatment period. Based on similar weight loss studies with obesity drugs, the covariance matrix for body weight change over time is estimated as AR(1) (sigma = 3.07, rho = 0.9). Thus, with 20 subjects completing each treatment group, this study can detect a mean difference of 6 kg between HSG4112 and matching placebo treatments with 80% power, assuming a two-sided α-level of 0.05. Therefore, the target sample size for this study is 20 subjects/group.
- Study Design and Protocol
This study is a randomized, double-blind, placebo-controlled, parallel-groups trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 4 treatment groups - 1 group receiving placebo - in a 1:1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 12 weeks according to the study protocol. Body weight and obesity/metabolism-related parameters will be evaluated to assess the efficacy of HSG4112. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory tests, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of HSG4112. Blood samples will be collected for pharmacokinetic assessment and samples from subjects who have signed the consent form for the exploratory genetic research will undergo analysis to detect PON2 gene polymorphism.
- 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 administration
PlaceboDrug
Once-daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| HSG4112 200 mg Multiple Dose | Experimental | Multiple oral dosing of HSG4112 200 mg for 12 weeks Receives: Drug: HSG4112 |
| HSG4112 400 mg Multiple Dose | Experimental | Multiple oral dosing of HSG4112 400 mg for 12 weeks Receives: Drug: HSG4112 |
| HSG4112 600 mg Multiple Dose | Experimental | Multiple oral dosing of HSG4112 600 mg for 12 weeks Receives: Drug: HSG4112 |
| Placebo | Placebo comparator | Multiple oral dosing of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (kg) from Baseline to End of Treatment
Change in body weight (kg)
Measured: Day 1 to Week 12
Evaluation of Safety and Tolerability by Adverse Event Monitoring
Number of adverse events, adverse drug reactions, serious adverse events, and suspected unexpected serious adverse reactions
Measured: Day -1 to 4 weeks following the last administration (Week 16)
Secondary outcomes (4)
Percentage of Subjects with ≥5% Body Weight Loss from Baseline to End of Treatment
Percentage of subjects (%) with ≥5% body weight loss
Measured: Day 1 to Week 12
Percentage of Subjects with ≥7% Body Weight Loss from Baseline to End of Treatment
Percentage of subjects (%) with ≥7% body weight loss
Measured: Day 1 to Week 12
Percentage of Subjects with ≥10% Body Weight Loss from Baseline to End of Treatment
Percentage of subjects (%) with ≥10% body weight loss
Measured: Day 1 to Week 12
Percent Change in Body Weight from Baseline to End of Treatment
Percent change (%) in body weight
Measured: Day 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start24 Feb 2022
- Primary completion31 Dec 2022
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaceum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gangnam Severance Hospital, Seoul National University Bundang Hospital, Korea University Anam Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- Hyuktae Kwon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197556
- Sponsor's protocol ID
- HSG4112-P2-01
- Status last verified
- Jun 2022
- First submitted
- 5 Jan 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Min K, Oh B, Koo HY, Kim YH, Lee JW, Lee S, Kim Y, Kwon H. Effect of anti-obesity agent HSG4112 on overweight and obese patients following 12 weeks of oral treatment: a study protocol for a randomised, double-blind, placebo-controlled, parallel-group, phase 2a clinical trial. Front Pharmacol. 2023 Aug 24;14:1177539. doi: 10.3389/fphar.2023.1177539. eCollection 2023.
PubMed 37693914
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients Following 12 Weeks of Oral Treatment
- ClinicalTrials.gov ID
- NCT05197556
- Acronym / sponsor ID
- HSG4112-P2-01
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- GlaceumIndustry (pharma, biotech, devices)
- Collaborators
- Gangnam Severance Hospital, Seoul National University Bundang Hospital, Korea University Anam Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 19 Jan 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 assess the effect of HSG4112 on body weight
- To evaluate the safety and tolerability of HSG4112
- Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of HSG4112 in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the safety and efficacy of HSG4112 in overweight and obese patients.
- Number of Subjects This study is a Phase 2a clinical trial designed to evaluate the safety and efficacy of HSG4112 following multiple-dose administration. The subject sample size estimate for the primary efficacy endpoint was based on total body weight, and assumes repeated measurement of body weight occurs at Baseline and every 4 weeks thereafter during the 12-week treatment period. Based on similar weight loss studies with obesity drugs, the covariance matrix for body weight change over time is estimated as AR(1) (sigma = 3.07, rho = 0.9). Thus, with 20 subjects completing each treatment group, this study can detect a mean difference of 6 kg between HSG4112 and matching placebo treatments with 80% power, assuming a two-sided α-level of 0.05. Therefore, the target sample size for this study is 20 subjects/group.
- Study Design and Protocol
This study is a randomized, double-blind, placebo-controlled, parallel-groups trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 4 treatment groups - 1 group receiving placebo - in a 1:1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 12 weeks according to the study protocol. Body weight and obesity/metabolism-related parameters will be evaluated to assess the efficacy of HSG4112. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory tests, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of HSG4112. Blood samples will be collected for pharmacokinetic assessment and samples from subjects who have signed the consent form for the exploratory genetic research will undergo analysis to detect PON2 gene polymorphism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSG4112 200 mg Multiple Dose | Experimental | Drug: HSG4112Multiple oral dosing of HSG4112 200 mg for 12 weeks |
| HSG4112 400 mg Multiple Dose | Experimental | Drug: HSG4112Multiple oral dosing of HSG4112 400 mg for 12 weeks |
| HSG4112 600 mg Multiple Dose | Experimental | Drug: HSG4112Multiple oral dosing of HSG4112 600 mg for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMultiple oral dosing of placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to comprehend and willing to sign an informed consent form approved by the IRB before Screening.
- 19 to 70 years, inclusive, at Screening.
- BMI is 30 to 39.9 kg/m2, inclusive (obese), with or without comorbid conditions, or BMI is 27 to 29.9 kg/m2, inclusive (overweight), with at least 1 documented treated or untreated comorbid condition (e.g., hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea). All comorbid conditions must be considered by the Investigator to be clinically stable.
- ☞ (BMI (kg/m2) = Weight (kg) / {Height (m)2})
- Eligible females will be:
Key exclusion criteria (42 listed)
- Clinically significant new illness, per Investigator judgment, in the 1 month before Screening and during the screening period.
- Significant history or clinical manifestation of allergic reaction or hypersensitivity to the investigational product or any related drug compound.
- Compliance with placebo self-administration is ≤80% during the 2-week single-blind placebo run-in period.
- Weight loss >3% during the 2-week single-blind placebo run-in period.
- Diabetes mellitus (type 1, type 2, or other). A remote history of gestational diabetes that has resolved is not exclusionary.
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 administration | Drug | HSG4112 200 mg Multiple Dose, HSG4112 400 mg Multiple Dose, HSG4112 600 mg Multiple Dose |
| PlaceboOnce-daily oral administration | Drug | Placebo |
Primary outcome
Change in Body Weight (kg) from Baseline to End of Treatment
Time frame: Day 1 to Week 12
Change in body weight (kg)
Evaluation of Safety and Tolerability by Adverse Event Monitoring
Time frame: Day -1 to 4 weeks following the last administration (Week 16)
Number of adverse events, adverse drug reactions, serious adverse events, and suspected unexpected serious adverse reactions
4 secondary outcomes
Percentage of Subjects with ≥5% Body Weight Loss from Baseline to End of Treatment
Time frame: Day 1 to Week 12
Percentage of Subjects with ≥7% Body Weight Loss from Baseline to End of Treatment
Time frame: Day 1 to Week 12
Percentage of Subjects with ≥10% Body Weight Loss from Baseline to End of Treatment
Time frame: Day 1 to Week 12
Percent Change in Body Weight from Baseline to End of Treatment
Time frame: Day 1 to Week 12
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 19 Mar 2024.
- Derived from this study: PubMed 37693914Min K, Oh B, Koo HY, Kim YH, Lee JW, Lee S, Kim Y, Kwon H. Effect of anti-obesity agent HSG4112 on overweight and obese patients following 12 weeks of oral treatment: a study protocol for a randomised, double-blind, placebo-controlled, parallel-group, phase 2a clinical trial. Front Pharmacol. 2023 Aug 24;14:1177539. doi: 10.3389/fphar.2023.1177539. eCollection 2023.
- 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.
Hyuktae Kwon, 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 2 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 10 inclusion and 42 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 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Body Weight (kg) from Baseline to End of Treatment (time frame: Day 1 to Week 12). The study lists 2 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 NCT05197556, which also lists 1 linked publication.
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 19 Mar 2024.