A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients

NCT05197556 | Completed Phase 2

• 1 other identifier: HSG4112-P2-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

• To assess the effect of HSG4112 on body weight
• To evaluate the safety and tolerability of HSG4112
• Background
• Number of Subjects
• Study Design and Protocol

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight (kg) from Baseline to End of Treatment

  Change in body weight (kg)

  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

  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

  Day 1 to Week 12

• Percentage of Subjects with ≥7% Body Weight Loss from Baseline to End of Treatment

  Day 1 to Week 12

• Percentage of Subjects with ≥10% Body Weight Loss from Baseline to End of Treatment

  Day 1 to Week 12

• Percent Change in Body Weight from Baseline to End of Treatment

  Day 1 to Week 12

Study Arms (4)

HSG4112 200 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of HSG4112 200 mg for 12 weeks

Drug: HSG4112

HSG4112 400 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of HSG4112 400 mg for 12 weeks

Drug: HSG4112

HSG4112 600 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of HSG4112 600 mg for 12 weeks

Drug: HSG4112

Placebo

PLACEBO COMPARATOR

Multiple oral dosing of placebo

Drug: Placebo

Interventions

HSG4112 DRUG

Once-daily oral administration

Also known as: 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol

HSG4112 200 mg Multiple Dose; HSG4112 400 mg Multiple Dose; HSG4112 600 mg Multiple Dose

Placebo DRUG

Once-daily oral administration

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and willing to sign an informed consent form approved by the IRB before Screening.
• 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
• 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.

You may not qualify if:

• 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.
• 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)
• 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.

Sponsors & Collaborators

• Glaceum: lead
• Gangnam Severance Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Seoul National University Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37693914 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyuktae Kwon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: February 24, 2022
• Primary Completion: December 31, 2022
• Study Completion: April 4, 2023
• Last Updated: March 19, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)