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

NCT04167553 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HM-GCG-102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obese With Comorbidities; Overweight With Comorbidities; Type2 Diabetes

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Serum Lipid Profiles

  Change from baseline to end of treatment (12 weeks)

Study Arms (2)

HM15136

EXPERIMENTAL

HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg

Drug: HM15136

Placebo

PLACEBO COMPARATOR

Matching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg

Drug: Placebo

Interventions

HM15136 DRUG

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.

Also known as: Part 1, 2

HM15136

Placebo DRUG

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.

Also known as: Part 1, 2

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Prosciento

San Diego, California, 91911, United States

Location

MeSH Terms

Interventions

HM15136

Results Point of Contact

• Title: Jiyeon Kang
• Organization: Hanmi Pharmaceutical Co., Ltd.

jiyeon.kang@hanmi.co.kr

+8224100377

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: August 30, 2019
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-01

Locations

US (1)