Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

NCT07677891 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PG-102-P2-03
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, multi-center, active-controlled Phase 2 clinical trial to evaluate the efficacy and safety of switching from once-weekly dulaglutide to PG-102(MG12) in patients with type 2 diabetes mellitus receiving stable dulaglutide therapy. The treatment period is 32 weeks, with an additional 4-week safety follow-up. The primary endpoint is the change in HbA1c(%) from baseline at Week 32.

Conditions

Type 2 Diabetes

Keywords

PG-102; ProGen; Type 2 Diabetes; GLP-1/GLP-2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from Baseline at Week 32

  Percent change in glycated hemoglobin (HbA1c, %) from baseline to Week 32

  [Time Frame: Baseline to Week 32]

Secondary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  [Time Frame: Baseline to Week 36]

• Percent Change in HbA1c from Baseline

  [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, and 36]

• Percent Change in Fasting Plasma Glucose (FPG) from Baseline

  [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]

• Absolute Change in Fasting Plasma Glucose (FPG) from Baseline

  [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]

• Percent Change in Body Weight from Baseline

  [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]

Study Arms (3)

PG-102(MG12) 60mg

EXPERIMENTAL

PG-102(MG12) 60 mg (N=20). Subcutaneous Injection with dose titration: Once weekly for 4 weeks, once every 2 weeks for 4 weeks, then once every 4 weeks for 24 weeks

Drug: PG-102(MG12)

PG-102(MG12) 90mg

EXPERIMENTAL

PG-102(MG12) 90 mg (N=20). Subcutaneous Injection with dose titration: Once weekly for 4 weeks, once every 2 weeks for 4 weeks, then once every 4 weeks for 24 weeks

Drug: PG-102(MG12)

Dulaglutide

ACTIVE COMPARATOR

Continued dulaglutide at current maintenance dose (N=20). Subcutaneous injection once weekly per label

Drug: Dulaglutide

Interventions

PG-102(MG12) DRUG

GLP-1 and GLP-2 fusion protein

PG-102(MG12) 60mg; PG-102(MG12) 90mg

Dulaglutide DRUG

GLP-1 receptor agonist

Dulaglutide

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 75 years who provide informed consent.
• Diagnosed with type 2 diabetes for at least 6 months prior to screening.
• Stable on dulaglutide therapy (0.75 or 1.5 mg) for at least 12 weeks prior to screening, with dose and dosing interval maintained unchanged for 8 weeks prior to enrollment.
• HbA1c ≤ 7.5% at screening.
• If receiving oral anti-diabetic drugs (OADs), on a stable dose for at least 90 days prior to screening.
• BMI between 18.5 kg/m² and 30.0 kg/m².

You may not qualify if:

• Received any investigational medicinal product within 30 days prior to screening, or within 5 half-lives of the product if known (whichever is longer).
• History of hypersensitivity or severe adverse reactions to GLP-1RA, GLP-2 agents, the investigational product, or its components.
• Type 1 diabetes, special forms of diabetes (e.g., monogenic, post-pancreatectomy, steroid-induced), or history of DKA or HHS within 6 months prior to screening
• Severe gastrointestinal disorders affecting gastric emptying (e.g., gastroparesis, inflammatory bowel disease, gastric/duodenal ulcer, intestinal obstruction) or history of related surgery within the past year (e.g., sleeve gastrectomy, biliopancreatic diversion, jejunal/ileal bypass).
• Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg) or severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL) despite appropriate treatment. Patients may be enrolled if these conditions are adequately controlled during screening.
• NYHA Class III or IV heart failure; acute coronary syndrome (including MI), unstable angina, clinically significant CAD (CCS Class III-IV), CABG or emergent PCI, TIA, or cerebrovascular accident within the past 6 months. Patients may be enrolled if the event occurred \>6 months ago and is considered resolved or stable.
• Active pancreatitis, history of recurrent or severe pancreatitis, or clinically significant gallbladder disease (e.g., cholecystitis, complications from gallstones) that is unresolved or at risk of recurrence.
• Active malignancy or history of malignancy treatment within the past 5 years. Exceptions: completely cured basal cell carcinoma, cervical carcinoma in situ, or other cured malignancies with no risk of recurrence as judged by the investigator.
• Personal or family history (first-degree relatives) of MEN type 2 or thyroid C-cell carcinoma (e.g., MTC). Exception: surgically cured simple thyroid nodules or benign non-C-cell thyroid conditions (e.g., thyroid adenoma, thyroid dysfunction).
• Active infectious disease (e.g., active TB, active viral hepatitis, HIV), or confirmed HBsAg-positive, HCV RNA-positive, or HIV infection, unless documented to be completely cured or currently inactive.
• History of hospitalization or emergency treatment for moderate or severe depressive disorder, bipolar disorder, or schizophrenia spectrum disorder within the past year. Exception: patients whose symptoms are currently stable under appropriate treatment and deemed safe to participate as assessed by the investigator.
• Therapeutic use of systemic corticosteroids for more than 14 days within 90 days prior to screening. Exception: short-term use (≤10 days) or non-absorbable topical, inhaled, intra-articular, or dermatological formulations.
• Diagnosis of or clinically suspected alcohol or drug abuse or dependence within 90 days prior to screening.
• AST or ALT \>3× ULN or total bilirubin \>2× ULN at screening. Exception: transient elevations confirmed to have normalized or to be stable on repeat testing.
• Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m² calculated by CKD-EPI equation.

Sponsors & Collaborators

• ProGen. Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Youngmin Cho, MD

CONTACT

82-2-6098-2818; bd@progen.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, open-label, active-controlled study evaluating the efficacy and safety of PG-102 compared with dulaglutide in participants with type 2 diabetes mellitus

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06