NCT03374241

Brief Summary

Single ascending dose of HM15211 in healthy obese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

May 17, 2024

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 12, 2017

Results QC Date

March 30, 2021

Last Update Submit

January 23, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (5)

Cohort 1

EXPERIMENTAL

HM15211 or Placebo (single dose, subcutaneous injection)

Biological: HM15211 or Placebo

Cohort 2

EXPERIMENTAL

HM15211 or Placebo (single dose, subcutaneous injection)

Biological: HM15211 or Placebo

Cohort 3

EXPERIMENTAL

HM15211 or Placebo (single dose, subcutaneous injection)

Biological: HM15211 or Placebo

Cohort 4

EXPERIMENTAL

HM15211 or Placebo (single dose, subcutaneous injection)

Biological: HM15211 or Placebo

Cohort 5

EXPERIMENTAL

HM15211 or Placebo (single dose, subcutaneous injection)

Biological: HM15211 or Placebo

Interventions

HM15211 or PlaceboBIOLOGICAL

Long-acting tri-agonist

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Investigative Site

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
khseo@hanmi.co.kr
Organization
HanmiPharma
khseo@hanmi.co.kr
+82 2 410 9042

Study Officials

  • Hanmi Pharmaceuticals

    Hanmi Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 15, 2017

Study Start

April 4, 2018

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

February 6, 2025

Results First Posted

May 17, 2024

Record last verified: 2025-01

Locations

US(1)