Type 2 Diabetes Mellitus (T2DM)Phase 2NCT07187856
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
A Phase 2 study testing PG-102 and Semaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by ProGen. Co., Ltd. at 1 site in Australia.
Trial summary
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- PG-102 and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2026to Dec 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF).
- Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria.
- Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening.
- Body mass index (BMI) ≥25 to <40 kg/m2 at screening.
Who cannot join
- Have a diagnosis of type 1 diabetes.
- History of severe hypoglycaemia and/or hypoglycaemia unawareness within 6 months prior to screening.
- Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening.
- Diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator (or delegate).
- Have known liver disease or obvious clinical signs or symptoms of liver disease, including acute or chronic hepatitis; or have any of the following at screening: ALT ≥ 3 × ULN, AST ≥ 3 × ULN, and total bilirubin ≥2 × ULN.
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- Concomitant therapy in addition to metformin therapy with another oral antihyperglycaemic medication (OAM) including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransport 2 inhibitors, alpha-glucosidase inhibitors, and meglitinides. Participants may be randomised if the additional OAM was discontinued at least 3 months prior to screening.
- Have used insulin for diabetic control within the prior year; however, short-term use of insulin for acute conditions is allowed (≤14 days) in certain situations, such as during a hospitalisation or perioperatively.
- Have had any exposure to GLP-1 analogues (including combination products) or other related compounds within the prior 3 months prior to screening, or any history ever of allergies to these medications. Patients who previously took GLP-1 analogues or related compounds and who discontinued those medications for intolerability or lack of efficacy will not be randomised.
- Have been treated with prescription drugs that promote weight loss or similar body weight loss medications including over-the-counter medications within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Emeritus Research
Camberwell, Victoria, 3124
Rishi Shah, 0395096166, rishishah@emeritusresearch.com
About this study
Official title: A Phase 2 Randomised Controlled Study to Investigate the Efficacy and Safety of Subcutaneously Administered PG-102 for 24 Weeks Compared With Placebo and Open-Label Semaglutide in Patients With Type 2 Diabetes Mellitus
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- PG-102, Placebo, Semaglutide
- 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-102Drug
PG-102 is administered subcutaneously once weekly with a titration regimen.
PlaceboDrug
Placebo is administered subcutaneously once weekly.
SemaglutideDrug
Open-label semaglutide is administered subcutaneously once weekly with titration regimen.
| Study group | Role | What they receive |
|---|---|---|
| PG-102 | Experimental | Participants receive PG-102 administered subcutaneously once weekly with dose titration. Receives: Drug: PG-102 |
| Placebo | Placebo comparator | Participants receive matching placebo administered subcutaneously once weekly. Receives: Drug: Placebo |
| Semaglutide | Active comparator | Participants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in HbA1c From Baseline at Week 24
Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.
Measured: 24 weeks
Secondary outcomes (8)
Absolute change in HbA1c from baseline to 12 weeks
Mean absolute change in HbA1c from baseline to Week 12.
Measured: 12 weeks
Absolute Change in Body Weight From Baseline at Week 12 and 24
Mean absolute change in body weight from baseline to Weeks 12 and 24.
Measured: 12 and 24 weeks
Percent Change in Body Weight From Baseline at Week 12 and 24
Mean percent change in Body Weight from baseline to Week 12 and 24.
Measured: 12 and 24 weeks
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24.
Mean change in fasting plasma glucose (mg/dL) from baseline to Week 12 and 24.
Measured: 12 and 24 weeks
Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.
Mean change in the 7-point SMPG profile from baseline to Week 12 and 24.
Measured: 12 and 24 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number and percentage of participants experiencing TEAEs, SAEs, and discontinuations due to adverse events.
Measured: 24 weeks
Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal
Incidence and severity of GI-related AESIs (e.g., nausea, vomiting, diarrhea).
Measured: 24 weeks
Incidence of anti-drug antibodies (ADA) to PG-102
Number and percentage of participants developing anti-drug antibodies against PG-102.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT07187856
- Sponsor's protocol ID
- PG-102-P2-WW-01
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomised Controlled Study to Investigate the Efficacy and Safety of Subcutaneously Administered PG-102 for 24 Weeks Compared With Placebo and Open-Label Semaglutide in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07187856
- Acronym / sponsor ID
- PG-102-P2-WW-01
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ProGen. Co., Ltd.University, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PG-102 | Experimental | Drug: PG-102Participants receive PG-102 administered subcutaneously once weekly with dose titration. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive matching placebo administered subcutaneously once weekly. |
| Semaglutide | Active comparator | Drug: SemaglutideParticipants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF).
- Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria.
- Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening.
- Body mass index (BMI) ≥25 to <40 kg/m2 at screening.
Key exclusion criteria (10 listed)
- Have a diagnosis of type 1 diabetes.
- History of severe hypoglycaemia and/or hypoglycaemia unawareness within 6 months prior to screening.
- Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening.
- Diagnosis of gastroparesis or history of bariatric surgery or a clinically significant gastric emptying abnormality, in the opinion of the investigator (or delegate).
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-102PG-102 is administered subcutaneously once weekly with a titration regimen. | Drug | PG-102 |
| PlaceboPlacebo is administered subcutaneously once weekly. | Drug | Placebo |
| SemaglutideOpen-label semaglutide is administered subcutaneously once weekly with titration regimen. | Drug | Semaglutide |
Primary outcome
Absolute change in HbA1c From Baseline at Week 24
Time frame: 24 weeks
Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.
8 secondary outcomes
Absolute change in HbA1c from baseline to 12 weeks
Time frame: 12 weeks
Absolute Change in Body Weight From Baseline at Week 12 and 24
Time frame: 12 and 24 weeks
Percent Change in Body Weight From Baseline at Week 12 and 24
Time frame: 12 and 24 weeks
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24.
Time frame: 12 and 24 weeks
Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.
Time frame: 12 and 24 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 24 weeks
Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal
Time frame: 24 weeks
Incidence of anti-drug antibodies (ADA) to PG-102
Time frame: 24 weeks
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 23 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG-102 and Semaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by ProGen. Co., Ltd. at 1 site in Australia.
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 5 inclusion and 10 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Kyunghwa Son, Ph.D (+82-2-6098-2818, khson@progen.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in HbA1c From Baseline at Week 24 (time frame: 24 weeks). 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 23 Sep 2025.