NCT07527650

Brief Summary

This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.

Trial Health

63
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Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
17mo left

Started May 2026

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Oct 2027

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Type 2 Diabetes MellitusT2DM

Keywords

Type 2 Diabetes MellitusT2DM

Outcome Measures

Primary Outcomes (1)

  • Change in Glycated Hemoglobin (HbA1c)

    Change in HbA1c (%) from randomization to Week 37.

    Up to 41 weeks

Secondary Outcomes (2)

  • Percentage of participants reaching specified HbA1c (%)

    Up to 41 weeks

  • Number of participants with adverse events (AEs)

    Up to 41 weeks

Other Outcomes (1)

  • Plasma concentration profile

    Up to 41 weeks

Study Arms (2)

HM15275

EXPERIMENTAL

Participants will receive HM15275 via subcutaneous (SC) injection.

Drug: HM15275

Placebo of HM15275

PLACEBO COMPARATOR

Participants will receive placebo of HM15275 via subcutaneous (SC) injection.

Drug: Placebo of HM15275

Interventions

HM15275DRUG

HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.

HM15275
Placebo of HM15275DRUG

A sterile, matching solution supplied in pre-filled syringes.

Placebo of HM15275

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant's age at the time of signing the informed consent:
  • United States: 18 to 75 years (inclusive)
  • Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
  • Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
  • BMI ≥25 kg/m² and ≤50 kg/m²
  • Body weight change \<5% over the past 3 months prior to screening
  • Capable of giving signed informed consent and willing to comply with all protocol procedures

You may not qualify if:

  • Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
  • Poor glycemic control (fasting plasma glucose \>270 mg/dL)
  • History of diabetic ketoacidosis or severe hypoglycemia within 6 months
  • Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
  • History of pancreatitis or factors increasing the risk of pancreatitis
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
  • Clinically significant liver disease, renal impairment (eGFR \<60 mL/min/1.73 m²), or abnormal laboratory findings at screening
  • Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Pureun Nam

CONTACT

+82-2-410-9147pureun.nam@hanmi.co.kr

Hyeonho Choi

CONTACT

+82-2-410-9834hyeonho.choi@hanmi.co.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)