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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04167553

Enrollment

Registered

2019-11-19

Start date

2019-08-30

Completion date

2020-12-09

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

DRUGHM15136

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.

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

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

Countries

United States

Participant flow

Recruitment details

The study was to consist of up to 7 cohorts with a total of 102 subjects. Part 1 of the study was to consist of 3 sequential dosing cohorts, enrolling 12 subjects per cohort, for a total of 36 subjects. Part 2 of the study was to consist of up to 4 cohorts, with 30 subjects in Cohort 4 and 12 subjects per cohort for Cohorts 5-7, for a total of 66 subjects. However, during cohort 5 (0.06mg/kg) in Part 2, enrolled subjects safety data were evaluated, and decided to stop the cohort.

Pre-assignment details

During cohort 0.06mg/kg in Part 2(cohort 5), enrolled subjects safety data were evaluated, and decided to stop the cohort. The following cohorts, cohort 6-7, were not conducted since those were optional.

Participants by arm

Arm	Count
HM15136 0.02 mg/kg Part 1 HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.	9
HM15136 0.04 mg/kg Part 1 HM15136 0.04 mg/kg HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.	9
HM15136 0.06 mg/kg Part 1 HM15136 0.06 mg/kg HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.	9
Placebo Part 1 Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.	9
HM15136 0.02 mg/kg Part 2 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.	9
HM15136 0.06 mg/kg Part 2 HM15136 0.06 mg/kg Part 2 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.	3
Placebo Part 2 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.	4
Total	52

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG003	FG004	FG005
Overall Study	Lost to Follow-up	0	2	0	0	0
Overall Study	Physician Decision	0	0	0	2	2
Overall Study	Withdrawal by Subject	1	1	2	1	0

Baseline characteristics

Characteristic	HM15136 0.02 mg/kg Part 1	HM15136 0.04 mg/kg Part 1	HM15136 0.06 mg/kg Part 1	Placebo Part 1	HM15136 0.02 mg/kg Part 2	HM15136 0.06 mg/kg Part 2	Placebo Part 2	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	9 Participants	9 Participants	9 Participants	9 Participants	9 Participants	3 Participants	4 Participants	52 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	1 Participants	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	7 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	8 Participants	7 Participants	6 Participants	6 Participants	8 Participants	3 Participants	4 Participants	42 Participants
Region of Enrollment United States	9 participants	9 participants	9 participants	9 participants	9 participants	3 participants	4 participants	52 participants
Sex: Female, Male Female	7 Participants	3 Participants	4 Participants	4 Participants	6 Participants	1 Participants	0 Participants	25 Participants
Sex: Female, Male Male	2 Participants	6 Participants	5 Participants	5 Participants	3 Participants	2 Participants	4 Participants	27 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 3	0 / 4
other Total, other adverse events	1 / 9	2 / 9	4 / 9	2 / 9	2 / 9	0 / 3	3 / 4
serious Total, serious adverse events	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 3	0 / 4