Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities

A Phase 1, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities

The planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; Obese With Comorbidities; Overweight With Comorbidities
• Intervention / Treatment: Drug: HM15136; Drug: Placebo

Detailed Description

The current Phase I study was a two-part study. Part 1 was designed to assess the safety, PK, and pharmacodynamics (PD) after repeated doses of HM15136 in obese or overweight subjects with comorbidities (i.e., dyslipidemia and/or hypertension). Part 2 was designed to assess the safety, PK, and PD after repeated doses of HM15136 in obese or overweight subjects with T2DM and comorbidities (i.e., dyslipidemia and/or

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 91911
      • ProSciento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or Female subjects
2. Age ≥ 18 to ≤ 65 years at Screening visit
3. Body Mass Index ( BMI ≥ 30 kg/m 2 or 27 kg/m 2 with presence of comorbidities (Subjects in Part 1 and Subjects with Pre diabete s mellitus (DM) in Part 2: dyslipidemia and or hypertension except for Type 2 (T2) DM, T2DM subjects in Part 2: dyslipidemia and/or hypertension with T2DM) with/without medication treatment and have had stable weight for 3 months (weight changes less than 5%)

Exclusion Criteria:

1. Previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal surgery that may induce malabsorption, history of bowel resection > 20 cm, any malabsorption disorder, severe gastroparesis, any GI procedure for weight loss (including LAPBAND®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe GERD ) at Screening.
2. Use of antacids, anticoagulants, or drugs that directly modify gastrointestinal (GI) motility, including antacid s anticholinergics, anticonvulsants, serotonin type 3 (5HT3) antagonists, dopamine antagonists, opiates; anticoagulation within 2 weeks of screening (But, it is not limited to the above listed drugs.)
3. Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening independent of subjects being on antihypertensive medication or no t). But, if the results are out of the reference range at the screening visit, they can be tested again on another day. Subjects with uncontrolled hypertension may be rescreened after 3 months, following initiation or adjustment of antihyp ertensive therapy.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM15136; HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg	Drug: HM15136; In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. In the end of study, Part 2 of the study consisted of 2 cohorts comprising 16 subjects total.; Other Names: Part 1, 2
Placebo Comparator: Placebo; Matching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg	Drug: Placebo; In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. In the end of study, Part 2 of the study consisted of 2 cohorts comprising 16 subjects total.; Other Names: Part 1, 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate the Incidence of AEs	To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders	after multiple subcutaneous (SC) doses for 12 weeks
To Evaluate Serum Amylase Levels at 12 Weeks	To evaluate the incidence of clinical lab abnormalities of serum amylase	after multiple subcutaneous (SC) doses for 12 weeks
Change From Baseline in Tympanic Temperature	tympanic temperature change	after multiple subcutaneous (SC) doses for 12 weeks
Change From Baseline in 12-lead ECG Parameters	QT interval corrected for HR using Fridericia's correction [QTcF]	after multiple subcutaneous (SC) doses for 12 weeks
Injection Site Reactions	Injection site reactions occurance	after multiple subcutaneous (SC) doses for 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Lipid Profiles	Change Cholesterol from baseline to end of treatment (12 weeks)	Change from baseline to end of treatment (12 weeks)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: HM-GCG-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No