CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
HM15136 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04167553
NCT04167553Phase 1Completed
CompareCT.gov

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

Hanmi Pharmaceutical Company Limited·interventional·Posted Nov 19, 2019·Updated Jan 27, 2025

In Brief

A Phase 1 clinical trial evaluating HM15136 and Placebo for Obese With Comorbidities and 2 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 19, 2019
Enrollment StartAug 30, 2019
Primary CompletionDec 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.6 years ago

Interventions

HM15136drug

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.

Placebodrug

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.