Type2 Diabetes MellitusPhase 4NCT05611684
The Influencing Factors of 12 Week Efficacy of Polyethylene Glycol Losenatide in Type 2 Diabetes Patients
A Phase 4 study testing Polyethylene Glycol Losenatide in people with Type2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The effect of polyethylene glycol Losenatide on body fat, insulin resistance, weight, blood sugar, blood lipid, stomach volume and other factors in patients with type 2 diabetes through 12 week follow-up, and explore the factors affecting the efficacy, so as to provide more evidence-based medical basis for drug… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Polyethylene Glycol Losenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Type 2 diabetes was diagnosed according to World Health Organization(WHO) classification or other locally applicable diagnostic criteria.
- At least 8 weeks of simple diet control and physical exercise before screening; Type 2 diabetes patients with stable hypoglycemic drug treatment and insufficient blood glucose control within 8 weeks before screening.
- HbA1c≥7.5%.
- Body mass index (BMI) > 24kg /m2.
- Subjects agreed to maintain scientific diet and exercise habits throughout the study, regularly conduct self blood glucose monitoring (SMBG) and make records.
- Willing to sign the written informed consent and abide by the research protocol.
Who cannot join
- Any of the following drugs or treatments were used within one year before screening: GLP-1RA, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues.
- Long term (more than 7 consecutive days) intravenous administration, oral administration and intra-articular administration of corticosteroids received within 2 months prior to visit 1.
- Used drugs with weight control effect or performed surgery that may lead to unstable weight within 2 months before screening, or is currently in the weight loss plan and not in the maintenance stage.
- History of acute and chronic pancreatitis; History of myeloid C-cell carcinoma, MEN 2A or 2B syndrome, or related family history.
- Clinically significant abnormal gastric emptying.
- Any organ system tumors that have been treated or not treated within 5 years prior to visit 1.
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- Have received coronary angioplasty, coronary stent implantation, and coronary artery bypass surgery within 6 months prior to visit 1, and have experienced negligent compensatory heart failure (NYHA class III and IV of New York Heart Association), stroke or transient ischemic attack, unstable angina, myocardial infarction, and persistent and clinically significant arrhythmia.
- Acute metabolic complications occurred within 6 months prior to visit 1.
- Before screening, any laboratory test index meets the following standards: glutamic pyruvic transaminase>2.5 times or glutamic oxaloacetic transaminase>2.5 times; eGFR<45ml\/min\/1.73m2； Fasting triglyceride>5.64mmol /L.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jianhua Ma
Nanjing, Jiangsu, 210006
Jianhua Ma, Professor, +8618951670116, majianhua196503@126.com
About this study
Official title: Nanjing First Hospital, Nanjing Medical University
The effect of polyethylene glycol Losenatide on body fat, insulin resistance, weight, blood sugar, blood lipid, stomach volume and other factors in patients with type 2 diabetes through 12 week follow-up, and explore the factors affecting the efficacy, so as to provide more evidence-based medical basis for drug treatment and benefit patients.
Read the detailed description
The aim of the study is to investigate the factors influencing the efficacy of 12 week treatment with polyethylene glycol Losenatide in type 2 diabetes patients on the basis of diet and exercise. With the 12 week decrease of HbA1c<0.4% from the baseline as the cut-off value, the patients were divided into HbA1c decrease<0.4% group and HbA1c decrease ≥ 0.4% group. The clinical characteristics, laboratory indicators, blood glucose fluctuation of subgroups and gene spectrum differences between the groups were analyzed to provide reference for clinical accurate drug use.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Polyethylene Glycol Losenatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol LosenatideDrug
Also called Comparison before and after treatment
Treatment 0.2mg QW for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene Glycol Losenatide | Experimental | Trearment for 12 weeks Receives: Drug: Polyethylene Glycol Losenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar changes
Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.
Measured: 12 weeks
blood lipid changes
Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes
Measured: 12 weeks
Secondary outcomes (2)
Body composition analysis
Efficacy of polyethylene glycol Losenatide on body composition changes in patients with type 2 diabetes
Measured: 12 weeks
Inflammation factors
Effects of polyethylene glycol Losenatide on inflammation factors in Patients With Type 2 Diabetes Mellitus,after being intervened for 12 weeks,changes of Inflammation factors were observed, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, Doctor, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611684
- Sponsor's protocol ID
- KY20220825-03
- Status last verified
- Sep 2022
- First submitted
- 23 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gu R, Zhou Y, Kong X, Luo Y, Li H, Ma J. Polyethylene Glycol Loxenatide Selectively Reduces Adiposity While Preserving Lean Body Mass in Type 2 Diabetes: A 12-Week Clinical Study. Diabetes Metab Syndr Obes. 2026 Jul 10;19:592044. doi: 10.2147/DMSO.S592044. eCollection 2026.
PubMed 42453280Zhu L, Li H, Zhang Y, Tao S, Yan R, Luo Y, Shen Z, Li H, Kong X, Ma J. Efficacy of 12-week treatment with polyethylene glycol loxenatide in obesity or overweight patients with type 2 diabetes: a multicenter, prospective cohort study based on the flash glucose monitoring system. Front Endocrinol (Lausanne). 2026 May 19;17:1810786. doi: 10.3389/fendo.2026.1810786. eCollection 2026.
PubMed 42238245
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanjing First Hospital, Nanjing Medical University
- ClinicalTrials.gov ID
- NCT05611684
- Acronym / sponsor ID
- KY20220825-03
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Nov 2022 (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.
The effect of polyethylene glycol Losenatide on body fat, insulin resistance, weight, blood sugar, blood lipid, stomach volume and other factors in patients with type 2 diabetes through 12 week follow-up, and explore the factors affecting the efficacy, so as to provide more evidence-based medical basis for drug treatment and benefit patients.
Detailed description
The aim of the study is to investigate the factors influencing the efficacy of 12 week treatment with polyethylene glycol Losenatide in type 2 diabetes patients on the basis of diet and exercise. With the 12 week decrease of HbA1c<0.4% from the baseline as the cut-off value, the patients were divided into HbA1c decrease<0.4% group and HbA1c decrease ≥ 0.4% group. The clinical characteristics, laboratory indicators, blood glucose fluctuation of subgroups and gene spectrum differences between the groups were analyzed to provide reference for clinical accurate drug use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyethylene Glycol Losenatide | Experimental | Drug: Polyethylene Glycol LosenatideTrearment for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes was diagnosed according to World Health Organization(WHO) classification or other locally applicable diagnostic criteria.
- At least 8 weeks of simple diet control and physical exercise before screening; Type 2 diabetes patients with stable hypoglycemic drug treatment and insufficient blood glucose control within 8 weeks before screening.
- HbA1c≥7.5%.
- Body mass index (BMI) > 24kg /m2.
- Subjects agreed to maintain scientific diet and exercise habits throughout the study, regularly conduct self blood glucose monitoring (SMBG) and make records.
Key exclusion criteria (9 listed)
- Any of the following drugs or treatments were used within one year before screening: GLP-1RA, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues.
- Long term (more than 7 consecutive days) intravenous administration, oral administration and intra-articular administration of corticosteroids received within 2 months prior to visit 1.
- Used drugs with weight control effect or performed surgery that may lead to unstable weight within 2 months before screening, or is currently in the weight loss plan and not in the maintenance stage.
- History of acute and chronic pancreatitis; History of myeloid C-cell carcinoma, MEN 2A or 2B syndrome, or related family history.
- Clinically significant abnormal gastric emptying.
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 |
|---|---|---|
| Polyethylene Glycol LosenatideAlso: Comparison before and after treatmentTreatment 0.2mg QW for 12 weeks | Drug | Polyethylene Glycol Losenatide |
Primary outcome
blood sugar changes
Time frame: 12 weeks
Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.
blood lipid changes
Time frame: 12 weeks
Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes
2 secondary outcomes
Body composition analysis
Time frame: 12 weeks
Inflammation factors
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 42453280Gu R, Zhou Y, Kong X, Luo Y, Li H, Ma J. Polyethylene Glycol Loxenatide Selectively Reduces Adiposity While Preserving Lean Body Mass in Type 2 Diabetes: A 12-Week Clinical Study. Diabetes Metab Syndr Obes. 2026 Jul 10;19:592044. doi: 10.2147/DMSO.S592044. eCollection 2026.
- Derived from this study: PubMed 42238245Zhu L, Li H, Zhang Y, Tao S, Yan R, Luo Y, Shen Z, Li H, Kong X, Ma J. Efficacy of 12-week treatment with polyethylene glycol loxenatide in obesity or overweight patients with type 2 diabetes: a multicenter, prospective cohort study based on the flash glucose monitoring system. Front Endocrinol (Lausanne). 2026 May 19;17:1810786. doi: 10.3389/fendo.2026.1810786. eCollection 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. This study is not recruiting at the moment.
Jianhua Ma, Doctor study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene Glycol Losenatide in people with Type2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Ma, Doctor (+8618951670116 ext. +862552887091, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sugar changes (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611684, which also lists 2 linked publications.
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 10 Nov 2022.