Obese With ComorbiditiesPhase 1NCT04167553

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

A Phase 1 study testing HM15136 in people with Obese With Comorbidities and Overweight With Comorbidities, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes
What is being tested?: HM15136
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2019to 9 Dec 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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%)

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Prosciento
San Diego, California, 91911

Other trials in United States

About this study

Official title: 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

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

Read the 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

Conditions: Obese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes
Being tested: HM15136, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HM15136Drug
Also called Part 1, 2
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
Also called Part 1, 2
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.

Study groups in NCT04167553
Study group	Role	What they receive
HM15136	Experimental	HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg Receives: Drug: HM15136
Placebo	Placebo comparator	Matching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To Evaluate the Incidence of AEs
To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders
Measured: 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
Measured: after multiple subcutaneous (SC) doses for 12 weeks
Change From Baseline in Tympanic Temperature
tympanic temperature change
Measured: 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]
Measured: after multiple subcutaneous (SC) doses for 12 weeks
Injection Site Reactions
Injection site reactions occurance
Measured: after multiple subcutaneous (SC) doses for 12 weeks

Secondary outcomes (1)

Serum Lipid Profiles
Change Cholesterol from baseline to end of treatment (12 weeks)
Measured: Change from baseline to end of treatment (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 20199 Dec 2020

First posted19 Nov 2019
Study start30 Aug 2019
Primary completion9 Dec 2020
Study completion9 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obese With ComorbiditiesStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04167553
Sponsor's protocol ID: HM-GCG-102
Status last verified: Jan 2025
First submitted: 15 Nov 2019
Last updated: 27 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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RecruitingPhase 3
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
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RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
RecruitingPhase 2
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
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Recruiting
ENLIGHT Trial: ESG With Fundal Mucosal Ablation
Obesity, Obesity (Body Mass Index >30 kg/m2)

All Obese With Comorbidities trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04167553
Acronym / sponsor ID: HM-GCG-102
Conditions: Obese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 30 Aug 2019 (actual)
Primary completion: 9 Dec 2020 (actual)
Study completion: 9 Dec 2020 (actual)
First posted: 19 Nov 2019 (actual)
Results: Posted 27 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
HM15136	Experimental	Drug: HM15136HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg
Placebo	Placebo comparator	Drug: PlaceboMatching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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%)

Key exclusion criteria (3 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HM15136Also: Part 1, 2In 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	HM15136
PlaceboAlso: Part 1, 2In 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

Primary outcome

To Evaluate the Incidence of AEs
Time frame: 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
Time frame: 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
Time frame: after multiple subcutaneous (SC) doses for 12 weeks
tympanic temperature change
Change From Baseline in 12-lead ECG Parameters
Time frame: after multiple subcutaneous (SC) doses for 12 weeks
QT interval corrected for HR using Fridericia's correction [QTcF]
Injection Site Reactions
Time frame: after multiple subcutaneous (SC) doses for 12 weeks
Injection site reactions occurance

1 secondary outcome

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

Results and safety

Results posted to the registry on 27 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HM15136 0.02 mg/kg Part 1	9	8
HM15136 0.04 mg/kg Part 1	9	9
HM15136 0.06 mg/kg Part 1	9	6
Placebo Part 1	9	7
HM15136 0.02 mg/kg Part 2	9	6
HM15136 0.06 mg/kg Part 2	3	1
Placebo Part 2	4	4

Primary outcome: To Evaluate the Incidence of AEs

Time frame: after multiple subcutaneous (SC) doses for 12 weeks. Count of participants. Unit: Participants

Measure	HM15136 0.02 mg/kg Part 1 n = 9	HM15136 0.04 mg/kg Part 1 n = 9	HM15136 0.06 mg/kg Part 1 n = 9	Placebo Part 1 n = 9	HM15136 0.02 mg/kg Part 2 n = 6	HM15136 0.06 mg/kg Part 2 n = 2	Placebo Part 2 n = 4
Value	1	2	4	2	2	0	3

Population analysed: To evaluate Skin and subcutaneous tissue disorders occurance from baseline to end of treatment

Primary outcome: To Evaluate Serum Amylase Levels at 12 Weeks

Time frame: after multiple subcutaneous (SC) doses for 12 weeks. Mean (Standard Deviation). Unit: U/L

Measure	HM15136 0.02 mg/kg Part 1 n = 8	HM15136 0.04 mg/kg Part 1 n = 9	HM15136 0.06 mg/kg Part 1 n = 6	Placebo Part 1 n = 7	HM15136 0.02 mg/kg Part 2 n = 6	HM15136 0.06 mg/kg Part 2 n = 1	Placebo Part 2 n = 4
Value	0.1 (12.17)	-1.1 (8.13)	7.8 (8.93)	-3.6 (8.18)	-12.5 (50.69)	-2 (NA)	-11 (15.21)

Population analysed: incidence of clinical lab abnormalities comparing from baseline to end of treatment

Primary outcome: Change From Baseline in Tympanic Temperature

Time frame: after multiple subcutaneous (SC) doses for 12 weeks. Mean (Standard Deviation). Unit: Celsius

Measure	HM15136 0.02 mg/kg Part 1 n = 9	HM15136 0.04 mg/kg Part 1 n = 9	HM15136 0.06 mg/kg Part 1 n = 9	Placebo Part 1 n = 9	HM15136 0.02 mg/kg Part 2 n = 9	HM15136 0.06 mg/kg Part 2 n = 1	Placebo Part 2 n = 4
Value	-0.28 (0.471)	-0.08 (0.291)	-0.23 (0.372)	-0.10 (0.408)	-0.1 (0.533)	-0.1 (NA)	-0.03 (0.411)

Population analysed: Evaluation of body temperature from baseline to end or treatment

Primary outcome: Change From Baseline in 12-lead ECG Parameters

Time frame: after multiple subcutaneous (SC) doses for 12 weeks. Mean (Standard Deviation). Unit: msec

Measure	HM15136 0.02 mg/kg Part 1 n = 9	HM15136 0.04 mg/kg Part 1 n = 9	HM15136 0.06 mg/kg Part 1 n = 9	Placebo Part 1 n = 9	HM15136 0.02 mg/kg Part 2 n = 6	HM15136 0.06 mg/kg Part 2 n = 1	Placebo Part 2 n = 4
Value	-26.6 (22.40)	-13.5 (14.98)	20.5 (10.14)	-13.2 (14.02)	-10 (18.24)	10.3 (NA)	14.0 (10.85)

Population analysed: To evaluate 12-lead ECG parameters changes from baseline to end of treatment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Screening, week 1, week 3, week 5, week 9, week 13, week 17. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HM15136 0.02 mg/kg Part 1	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
HM15136 0.04 mg/kg Part 1	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
HM15136 0.06 mg/kg Part 1	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
Placebo Part 1	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
HM15136 0.02 mg/kg Part 2	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
HM15136 0.06 mg/kg Part 2	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Placebo Part 2	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obese With Comorbidities

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HM15136 in people with Obese With Comorbidities and Overweight With Comorbidities, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Evaluate the Incidence of AEs (time frame: after multiple subcutaneous (SC) doses for 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04167553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.