Type 2 DiabetesPhase 2NCT07677891
Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus
A Phase 2 study testing PG-102(MG12) and Dulaglutide in people with Type 2 Diabetes, run by ProGen. Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- PG-102(MG12) and Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Moderate or severe hepatic impairment (Child-Pugh Grade B or above) or currently active drug-induced liver disease. Exception: history of drug-induced liver disease with complete recovery and stable liver function tests (AST, ALT, total bilirubin) within normal range.
- "17. Severe or active diabetic complications, including:
- Proliferative diabetic retinopathy currently receiving or requiring treatment (laser, vitrectomy, anti-VEGF, or steroid injections) within the past 3 months or planned treatment. (Non-proliferative or stable retinopathy is permitted with fundus examination at screening and regular follow-up.)
- Diabetic nephropathy with overt proteinuria (≥300 mg/day) or eGFR <45 mL/min/1.73 m²
- Severe diabetic neuropathy with uncontrolled pain despite optimized pharmacotherapy (e.g., antidepressants, gabapentinoids, analgesics) for ≥3 months, requiring continuous use of opioid or multiple combination analgesics.
- Exception: patients with past complications that are currently stable and deemed safe to participate as assessed by the investigator." 18. Fertile women or fertile men (including those with fertile female partners) who do not agree to use dual contraception or abstinence from the time of written consent until 90 days after the last dose of investigational product. (Fertile women must have a negative serum pregnancy test during screening prior to study entry).
- 19. Currently pregnant or breastfeeding, or planning pregnancy during the study period or within 90 days after the last dose of investigational product.
- 20. Previous experience of persistent or recurrent vomiting or severe diarrhea requiring hospitalization, emergency treatment, or drug discontinuation following GLP-1 receptor agonist or GLP-2 analogue administration, or history of intestinal obstruction.
- 21. Patients who required dose reduction of dulaglutide due to intolerance and subsequently failed re-escalation to the previous dose. Exception: patients assessed by the investigator as currently maintaining stable treatment at the reduced dose.
- 22. History of or planned use of prohibited concomitant medications within 90 days prior to screening or during the study period. Exception: short-term use (≤14 days) for therapeutic necessity with no anticipated pharmacokinetic or pharmacodynamic interaction with the investigational product as judged by the investigator.
- 23. Use of insulin for diabetes management during the 1 year prior to screening. Exception: acute short-term use (≤14 days) during hospitalization or perioperative periods.
- 24. Patients deemed inappropriate for study participation by the investigator based on safety, compliance, or medical judgment (considering physical examination, baseline test results, medical history, etc.).
- 25. Self-reported body weight change of >5% within 12 weeks (90 days) prior to screening.
- 26. History of untreatable colorectal polyps. 27. Presence of factors that may affect IGF-1 measurement, such as growth hormone (GH) injections.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-Label, Multicenter, Active-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Switching From Once-Weekly Dulaglutide to Once-Monthly PG-102(MG12) in Patients With Type 2 Diabetes Mellitus Receiving Stable Dulaglutide Therapy
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.
Read the detailed description
Participants will be randomized 1:1:1 to three treatment arms: two PG-102(MG12) dose groups and one active-control group (dulaglutide), over a 32-week treatment period , with an additional 4-week safety follow-up.
PG-102(MG12) will be administered with a dose titration schedule: once weekly for the first 4weeks, once every 2 weeks for the following 4 weeks, and once every 4 weeks for the remaining 24 weeks.
The dulaglutide control group will continue their current maintenance dose once weekly per label.
- Conditions
- Type 2 Diabetes
- Being tested
- PG-102(MG12), Dulaglutide
- Keywords
- PG-102, ProGen, Type 2 Diabetes, GLP-1/GLP-2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-102(MG12)Drug
GLP-1 and GLP-2 fusion protein
DulaglutideDrug
GLP-1 receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: PG-102(MG12) |
| Dulaglutide | Active comparator | Continued dulaglutide at current maintenance dose (N=20). Subcutaneous injection once weekly per label Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from Baseline at Week 32
Percent change in glycated hemoglobin (HbA1c, %) from baseline to Week 32
Measured: [Time Frame: Baseline to Week 32]
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs) reported following administration of PG-102.
Measured: [Time Frame: Baseline to Week 36]
Percent Change in HbA1c from Baseline
Percent change in glycated hemoglobin (HbA1c, %) from baseline at Weeks 8, 12, 16, 20, 24, 28, and 36
Measured: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, and 36]
Percent Change in Fasting Plasma Glucose (FPG) from Baseline
Percent change in fasting plasma glucose (FPG, mg/dL) from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36.
Measured: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Absolute Change in Fasting Plasma Glucose (FPG) from Baseline
Absolute change in fasting plasma glucose (FPG, mg/dL) from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36.
Measured: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Percent Change in Body Weight from Baseline
Percent change in body weight from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36.
Measured: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Absolute Change in Body Weight from Baseline
Absolute change in body weight (kg) from baseline at Weeks 8, 12, 16, 20, 24, 28, 32, and 36.
Measured: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProGen. Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677891
- Sponsor's protocol ID
- PG-102-P2-03
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter, Active-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Switching From Once-Weekly Dulaglutide to Once-Monthly PG-102(MG12) in Patients With Type 2 Diabetes Mellitus Receiving Stable Dulaglutide Therapy
- ClinicalTrials.gov ID
- NCT07677891
- Acronym / sponsor ID
- PG-102-P2-03
- Conditions
- Type 2 Diabetes
- Keywords
- PG-102, ProGen, Type 2 Diabetes, GLP-1/GLP-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ProGen. Co., Ltd.University, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomized 1:1:1 to three treatment arms: two PG-102(MG12) dose groups and one active-control group (dulaglutide), over a 32-week treatment period , with an additional 4-week safety follow-up.
PG-102(MG12) will be administered with a dose titration schedule: once weekly for the first 4weeks, once every 2 weeks for the following 4 weeks, and once every 4 weeks for the remaining 24 weeks.
The dulaglutide control group will continue their current maintenance dose once weekly per label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PG-102(MG12) 60mg | Experimental | Drug: PG-102(MG12)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 |
| PG-102(MG12) 90mg | Experimental | Drug: PG-102(MG12)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 |
| Dulaglutide | Active comparator | Drug: DulaglutideContinued dulaglutide at current maintenance dose (N=20). Subcutaneous injection once weekly per label |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
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 |
|---|---|---|
| PG-102(MG12)GLP-1 and GLP-2 fusion protein | Drug | PG-102(MG12) 60mg, PG-102(MG12) 90mg |
| DulaglutideGLP-1 receptor agonist | Drug | Dulaglutide |
Primary outcome
Change in HbA1c from Baseline at Week 32
Time frame: [Time Frame: Baseline to Week 32]
Percent change in glycated hemoglobin (HbA1c, %) from baseline to Week 32
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: [Time Frame: Baseline to Week 36]
Percent Change in HbA1c from Baseline
Time frame: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, and 36]
Percent Change in Fasting Plasma Glucose (FPG) from Baseline
Time frame: [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: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Percent Change in Body Weight from Baseline
Time frame: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Absolute Change in Body Weight from Baseline
Time frame: [Time Frame: Baseline to Weeks 8, 12, 16, 20, 24, 28, 32, and 36]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG-102(MG12) and Dulaglutide in people with Type 2 Diabetes, run by ProGen. Co., Ltd..
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 6 inclusion and 29 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youngmin Cho, MD (82-2-6098-2818, bd@progen.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from Baseline at Week 32 (time frame: [Time Frame: Baseline to Week 32]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.