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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT04167553

Collaborator

(none)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obese With Comorbidities Overweight With Comorbidities Type2 Diabetes	Drug: HM15136 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15136 in Obese or Overweight Subjects With Comorbidities

Actual Study Start Date :

Aug 30, 2019

Actual Primary Completion Date :

Dec 9, 2020

Actual Study Completion Date :

Dec 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HM15136	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.
Placebo Comparator: Placebo	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.

Arm

Intervention/Treatment

Experimental: HM15136

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.

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

adverse events (AEs): [after multiple subcutaneous (SC) doses for 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prosciento	San Diego	California	United States	91911

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04167553

Other Study ID Numbers:

HM-GCG-102

First Posted:

Nov 19, 2019

Last Update Posted:

Apr 5, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Apr 5, 2021