MedTrace Logo

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

NCT04167553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-01-27

Study results available
· View outcomes & findings →

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2020-12-09
Completion
2020-12-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167553 on ClinicalTrials.gov