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A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211(Efocipegtrutide) in Healthy Obese Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03374241
Enrollment
41
Registered
2017-12-15
Start date
2018-04-04
Completion date
2018-09-14
Last updated
2025-02-06

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

Conditions

Obesity

Brief summary

Single ascending dose of HM15211 in healthy obese subjects.

Detailed description

A First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics after single ascending dose of HM15211 in healthy obese subjects.

Interventions

BIOLOGICALHM15211 or Placebo

Long-acting tri-agonist

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Female subjects must be non-pregnant and non-lactating

Exclusion criteria

* Participation in an investigational study within 30 days prior to dosing

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Adverse Events1 monthAn adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products

Countries

United States

Participant flow

Participants by arm

ArmCount
Cohort 1 Active
HM15211 0.01 mg/kg
6
Cohort 2 Active
HM15211 0.02 mg/kg
6
Cohort 3 Active
HM15211 0.04 mg/kg
6
Cohort 4 Active
HM15211 0.08 mg/kg
7
Cohort 5 Active
HM15211 0.12 mg/kg
6
Placebo
Placebo matched to the volume of the dose of HM15211
10
Total41

Baseline characteristics

CharacteristicTotalCohort 1 ActiveCohort 2 ActiveCohort 3 ActiveCohort 4 ActiveCohort 5 ActivePlacebo
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
41 Participants6 Participants6 Participants6 Participants7 Participants6 Participants10 Participants
Age, Continuous45.7 years
STANDARD_DEVIATION 11.38
41.0 years
STANDARD_DEVIATION 14.34
36.3 years
STANDARD_DEVIATION 11.78
54.0 years
STANDARD_DEVIATION 6.13
49.7 years
STANDARD_DEVIATION 11.06
43.8 years
STANDARD_DEVIATION 13.53
47.4 years
STANDARD_DEVIATION 6.55
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants1 Participants5 Participants1 Participants3 Participants4 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants5 Participants1 Participants5 Participants4 Participants2 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
12 Participants2 Participants1 Participants4 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
27 Participants4 Participants5 Participants2 Participants5 Participants6 Participants5 Participants
Region of Enrollment
United States
41 participants6 participants6 participants6 participants7 participants6 participants10 participants
Sex: Female, Male
Female
20 Participants3 Participants4 Participants2 Participants4 Participants2 Participants5 Participants
Sex: Female, Male
Male
21 Participants3 Participants2 Participants4 Participants3 Participants4 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 60 / 60 / 70 / 60 / 10
other
Total, other adverse events
3 / 62 / 63 / 67 / 74 / 67 / 10
serious
Total, serious adverse events
0 / 60 / 60 / 60 / 70 / 60 / 10

Outcome results

Primary

Number of Participants With Adverse Events

An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 1 ActiveNumber of Participants With Adverse Events3 Participants
Cohort 2 ActiveNumber of Participants With Adverse Events2 Participants
Cohort 3 ActiveNumber of Participants With Adverse Events3 Participants
Cohort 4 ActiveNumber of Participants With Adverse Events7 Participants
Cohort 5 ActiveNumber of Participants With Adverse Events4 Participants
PlaceboNumber of Participants With Adverse Events7 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026