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

Phase 1

Completed

Conditions: Obese With Comorbidities
Overweight With Comorbidities
Type2 Diabetes

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

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

Recruitment & Eligibility

Inclusion Criteria

Male or Female subjects
Age ≥ 18 to ≤ 65 years at Screening visit
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

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.
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.)
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.)

Arm && Interventions

Group	Intervention	Description
HM15136	HM15136	HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg
Placebo	Placebo	Matching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg

Primary Outcome Measures

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