Type 1 DiabetesNCT07924553
Efficacy, Safety and Cardiovascular Protection of Mazdutide in Type 1 Diabetes
A study testing Mazdutide and Placbo in people with Type 1 Diabetes, run by Peking University People's Hospital.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with type 1 diabetes (T1D), conducted in two stages. Stage 1 is the efficacy and safety assessment (TIMES-EFFICACY). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Mazdutide and Placbo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jun 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at screening.
- Patients with a clinical diagnosis of T1D for at least 12 months.
- Patients with T1D must satisfy all three of the following features:
- Clinical diagnosis of type 1 diabetes by a specialist physician;
- Any one of the following: age at onset <15 years; no overweight or obesity at onset; diabetic ketoacidosis at onset; peak stimulated C-peptide <200 pmol/L;
- Any one of the following: continuous insulin therapy since diagnosis (excluding pancreas or islet transplantation); one or more positive pancreatic islet autoantibodies (GADA / IAA / IA-2A / ZnT8).
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- Willingness to use once-weekly mazdutide.
- HbA1c ≥7.0% and <10.0%.
- Body mass index (BMI) ≥20 kg/m².
- Continuous use of any of the following insulin regimens for at least 3 months prior to screening (no concomitant use of other oral glucose-lowering drugs or GLP-1RAs allowed), with a stable insulin dose for at least 2 weeks before enrollment:
- Multiple daily injections of basal insulin plus prandial insulin;
- Premixed insulin analog injected 2-3 times daily;
- Dual insulin analog (insulin degludec/aspart) injected twice daily;
- Continuous subcutaneous insulin infusion (CSII). Note: A stable insulin dose is defined as a daily insulin dose adjustment of no more than ±[value not specified in the source document].
- Ability to provide informed consent prior to any study-related activity.
- For participants enrolled in TIMES-CV, in addition to the above criteria, the following criteria must also be met: ***
- 1. Duration of type 1 diabetes ≥5 years. 2. Moderate or high 10-year atherosclerotic cardiovascular disease (ASCVD) risk (≥5.0%) as assessed by the China-PAR model.
- 3. Carotid atherosclerotic plaque confirmed by ultrasound.
Who cannot join
- Other types of diabetes.
- BMI <20 kg/m².
- History of cardiovascular disease: previous myocardial infarction, unstable angina, coronary revascularization (PCI or CABG), stroke, transient ischemic attack (TIA), or symptomatic peripheral arterial disease.
- Renal impairment: estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² (based on the CKD-EPI equation).
- Hepatic disease: known severe hepatic disease, or ALT/AST levels >3 times the upper limit of normal.
- Personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia syndrome type 2.
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- Pancreatic disease: history of acute or chronic pancreatitis.
- Pregnancy and lactation: women who are pregnant, breastfeeding, or planning pregnancy and unwilling to use effective contraception.
- Medications: use of GLP-1 receptor agonists, GIP or GCG receptor agonists, other non-insulin glucose-lowering drugs, or finerenone within 3 months prior to screening.
- Requirement for long-term use of systemic glucocorticoids (topical/inhaled use permitted).
- History of hypersensitivity to GLP-1 receptor agonists, mazdutide, or any of its excipients.
- Moderate or more severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy.
- Any other serious medical or psychiatric condition that, in the judgment of the investigator, may interfere with study assessments or endanger the safety of the subject.
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: Type 1 Diabetes Intervention With Mazdutide for Efficacy, Safety and Cardiovascular Protection (The TIMES Trial Program-TIMES-EFFICACY & TIMES-CV
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with type 1 diabetes (T1D), conducted in two stages.
Stage 1 is the efficacy and safety assessment (TIMES-EFFICACY). A total of 182 T1D patients who meet the inclusion criteria will be randomized in a 1:1 ratio to two groups: one receiving mazdutide and the other receiving placebo. The follow-up period is 16 weeks. The primary clinical endpoint is the proportion of patients achieving time in range (TIR) >70% with time below range (TBR) <4%. An interim analysis will be performed at Week 8; if the absolute TBR in the mazdutide group increases by more than 5% relative to the placebo group, the subsequent study will be terminated.
Stage 2 is the cardiovascular protective effect assessment (TIMES-CV). During the Stage 1 efficacy and safety assessment, a pre-specified stratification method will ensure that 104 patients with high cardiovascular risk factors are randomized in a 1:1 ratio to the mazdutide group or the placebo group. After completing the 16-week efficacy and safety assessment, these 104 subjects will continue to receive randomized controlled treatment and enter the cardiovascular effect assessment stage, with a total follow-up duration of 52 weeks. The primary clinical endpoint is the change in non-calcified coronary artery plaque volume.
- Conditions
- Type 1 Diabetes
- Being tested
- Mazdutide, Placbo
- Keywords
- type 1 diabetes, glucagon-like peptide-1 receptor agonist, glucagon receptor agonist, mazdutide
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MazdutideDrug
Mazdutide is a synthetic peptide analog of mammalian oxyntomodulin and a once-weekly dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), under development for the treatment of obesity and type 2 diabetes (T2D). Mazdutide has been shown to induce significant weight loss in patients with obesity and to help improve glycemic control in patients with T2D.
PlacboDrug
mazdutide matching placebo
| Study group | Role | What they receive |
|---|---|---|
| mazdutide group | Experimental | Participants in the treatment group will receive mazdutide by subcutaneous injection once weekly. The dose will be escalated stepwise according to a pre-defined regimen from a safe starting dose to an effective maintenance dose (from 2 mg to 4 mg) over several weeks, with dose reduction permitted if needed. Receives: Drug: Mazdutide |
| placebo group | Placebo comparator | Participants in the control group will receive a placebo matched to mazdutide in appearance, packaging, and mode of administration, by subcutaneous injection once weekly. Receives: Drug: Placbo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the participants achieving time in range (TIR)>70 and time below range (TBR)<4% (TIMES-EFFICACY)
The proportion of adult patients with T1D achieving the composite outcome of continuous glucose monitoring (CGM)-measured TIR >70% and TBR <4% at Week 16 in the mazdutide group versus the placebo group
Measured: From baseline to 16 weeks
Volume of non-calcified coronary artery plaque (TIMES-CV)
The absolute change in non-calcified coronary artery plaque volume in mm³ from baseline to Week 52, as measured by quantitative analysis of high-resolution coronary computed tomography angiography (CCTA)
Measured: From baseline to 52 weeks
Secondary outcomes (11)
Level of HbA1c
Changes in HbA1c (%) from baseline to Week 16 and Week 52
Measured: From baseline to 52 weeks
Volume of coronary atherosclerotic plaque
Changes in total coronary atherosclerotic plaque volume, fibrous plaque volume, low-density plaque volume, and lipid-rich plaque volume in mm³
Measured: From baseline to 52 weeks
Thickness of carotid intima-media
Changes in carotid intima-media thickness (cIMT) in mm from baseline to Week 52
Measured: From baseline to 52 weeks
Time in range (TIR)
Changes in TIR (%) from baseline to Week 52
Measured: From baseline to 52 weeks
Time above range (TAR)
Changes in TAR (%) from the baseline to Week 52
Measured: From baseline to 52 weeks
Time below range (TBR)
Changes in TBR (%) from baseline to Week 52
Measured: From baseline to 52 weeks
Covariation (CV)
Changes in CV (%) assessed by continuous glucose monitoring from baseline to Week 52
Measured: From baseline to 52 weeks
Level of triglyceride (TG)
Changes in TG (mmol/L) from baseline to Week 52
Measured: From baseline to 52 weeks
Level of total cholesterol (TC)
Changes in TC (mmol/L) from baseline to Week 52
Measured: From baseline to 52 weeks
Level of low-density cholesterol (LDL-C)
Changes in LDL-C (mmol/L) from baseline to Week 52
Measured: From baseline to 52 weeks
Level of high-density cholesterol (HDL-C)
Changes in HDL-C (mmol/L) from baseline to Week 52
Measured: From baseline to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, Shenzhen Second People's Hospital, Zhongnan Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Second Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University, Tangshan Worker's Hospital, Hebei General Hospital, Heji Hospital affiliated to Changzhi Medical College, Tianjin Medical University, The Second Hospital of Shijiazhuang
- Responsible party
- Principal investigator, Linong Ji, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924553
- Sponsor's protocol ID
- 2026PHD024-004
- Other IDs
- 3-SRA-2026-1955-M-B
- Status last verified
- Nov 2026
- First submitted
- 20 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) collected in this study available to researchers outside the primary research group. The study data will be kept confidential by the sponsor and investigators in accordance with applicable regulations and the study protocol. Sharing of IPD is not planned due to considerations regarding participant confidentiality and data protection.
Publications
Gao L, Jiang H, Cai H, Tian J, Shi B, Qiu W, Huang C, Han J, Zhang S, Pang S, Bi Y, Chen L, Gu X, Han J, Ma Q, Deng H, Wang Y, Li L, Han-Zhang H, Qian L, Ji L; GLORY-2 Trial Investigators. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):377-388. doi: 10.1001/jama.2026.8142.
PubMed 42251595Guo L, Zhang B, Xue X, Zhang X, Cai H, Jiang H, Zhang L, Jin P, Wang X, Cheng Z, Zhang S, Geng J, Guo Y, Hu H, Ma Q, Li L, Du H, Han-Zhang H, Xue F, Deng H, Qian L, Yang W; DREAMS-2 investigators. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature. 2026 Apr;652(8108):181-188. doi: 10.1038/s41586-025-10031-z. Epub 2025 Dec 17.
PubMed 41407860Zhu D, Zhao J, Cai H, Chu X, Xiu S, Song C, Cheng Z, Cao H, Jiang H, Zhang L, Wang H, Shi B, Li Y, Liu M, Feng B, Xue F, Deng H, Li H, Li L, Li Y, Ma Q, Qian L. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature. 2026 Apr;652(8108):174-180. doi: 10.1038/s41586-025-10026-w. Epub 2025 Dec 17.
PubMed 41407859Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.
PubMed 40421736Shirley M. Mazdutide: First Approval. Drugs. 2025 Dec;85(12):1621-1627. doi: 10.1007/s40265-025-02249-y. Epub 2025 Sep 30.
PubMed 41028652Pasqua MR, Tsoukas MA, Kobayati A, Aboznadah W, Jafar A, Haidar A. Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial. Nat Med. 2025 Apr;31(4):1239-1245. doi: 10.1038/s41591-024-03463-z. Epub 2025 Jan 10.
PubMed 39794615
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Intervention With Mazdutide for Efficacy, Safety and Cardiovascular Protection (The TIMES Trial Program-TIMES-EFFICACY & TIMES-CV
- ClinicalTrials.gov ID
- NCT07924553
- Acronym / sponsor ID
- 2026PHD024-004
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, glucagon-like peptide-1 receptor agonist, glucagon receptor agonist, mazdutide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, Shenzhen Second People's Hospital, Zhongnan Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Second Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University, Tangshan Worker's Hospital, Hebei General Hospital, Heji Hospital affiliated to Changzhi Medical College, Tianjin Medical University, The Second Hospital of Shijiazhuang
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 Nov 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 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients with type 1 diabetes (T1D), conducted in two stages.
Stage 1 is the efficacy and safety assessment (TIMES-EFFICACY). A total of 182 T1D patients who meet the inclusion criteria will be randomized in a 1:1 ratio to two groups: one receiving mazdutide and the other receiving placebo. The follow-up period is 16 weeks. The primary clinical endpoint is the proportion of patients achieving time in range (TIR) >70% with time below range (TBR) <4%. An interim analysis will be performed at Week 8; if the absolute TBR in the mazdutide group increases by more than 5% relative to the placebo group, the subsequent study will be terminated.
Stage 2 is the cardiovascular protective effect assessment (TIMES-CV). During the Stage 1 efficacy and safety assessment, a pre-specified stratification method will ensure that 104 patients with high cardiovascular risk factors are randomized in a 1:1 ratio to the mazdutide group or the placebo group. After completing the 16-week efficacy and safety assessment, these 104 subjects will continue to receive randomized controlled treatment and enter the cardiovascular effect assessment stage, with a total follow-up duration of 52 weeks. The primary clinical endpoint is the change in non-calcified coronary artery plaque volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mazdutide group | Experimental | Drug: MazdutideParticipants in the treatment group will receive mazdutide by subcutaneous injection once weekly. The dose will be escalated stepwise according to a pre-defined regimen from a safe starting dose to an effective maintenance dose (from 2 mg to 4 mg) over several weeks, with dose reduction permitted if needed. |
| placebo group | Placebo comparator | Drug: PlacboParticipants in the control group will receive a placebo matched to mazdutide in appearance, packaging, and mode of administration, by subcutaneous injection once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18 years at screening.
- Patients with a clinical diagnosis of T1D for at least 12 months.
- Willingness to use once-weekly mazdutide.
- HbA1c ≥7.0% and <10.0%.
- Body mass index (BMI) ≥20 kg/m².
Key exclusion criteria (13 listed)
- Other types of diabetes.
- BMI <20 kg/m².
- History of cardiovascular disease: previous myocardial infarction, unstable angina, coronary revascularization (PCI or CABG), stroke, transient ischemic attack (TIA), or symptomatic peripheral arterial disease.
- Renal impairment: estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² (based on the CKD-EPI equation).
- Hepatic disease: known severe hepatic disease, or ALT/AST levels >3 times the upper limit of normal.
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 |
|---|---|---|
| MazdutideMazdutide is a synthetic peptide analog of mammalian oxyntomodulin and a once-weekly dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), under development for the treatment of obesity and type 2 diabetes (T2D). Mazdutide has been shown to induce significant weight loss in patients with obesity and to help improve glycemic control in patients with T2D. | Drug | mazdutide group |
| Placbomazdutide matching placebo | Drug | placebo group |
Primary outcome
Proportion of the participants achieving time in range (TIR)>70 and time below range (TBR)<4% (TIMES-EFFICACY)
Time frame: From baseline to 16 weeks
The proportion of adult patients with T1D achieving the composite outcome of continuous glucose monitoring (CGM)-measured TIR >70% and TBR <4% at Week 16 in the mazdutide group versus the placebo group
Volume of non-calcified coronary artery plaque (TIMES-CV)
Time frame: From baseline to 52 weeks
The absolute change in non-calcified coronary artery plaque volume in mm³ from baseline to Week 52, as measured by quantitative analysis of high-resolution coronary computed tomography angiography (CCTA)
11 secondary outcomes
Level of HbA1c
Time frame: From baseline to 52 weeks
Volume of coronary atherosclerotic plaque
Time frame: From baseline to 52 weeks
Thickness of carotid intima-media
Time frame: From baseline to 52 weeks
Time in range (TIR)
Time frame: From baseline to 52 weeks
Time above range (TAR)
Time frame: From baseline to 52 weeks
Time below range (TBR)
Time frame: From baseline to 52 weeks
Covariation (CV)
Time frame: From baseline to 52 weeks
Level of triglyceride (TG)
Time frame: From baseline to 52 weeks
Level of total cholesterol (TC)
Time frame: From baseline to 52 weeks
Level of low-density cholesterol (LDL-C)
Time frame: From baseline to 52 weeks
Level of high-density cholesterol (HDL-C)
Time frame: From baseline to 52 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 9 Nov 2026.
- Background: PubMed 42251595Gao L, Jiang H, Cai H, Tian J, Shi B, Qiu W, Huang C, Han J, Zhang S, Pang S, Bi Y, Chen L, Gu X, Han J, Ma Q, Deng H, Wang Y, Li L, Han-Zhang H, Qian L, Ji L; GLORY-2 Trial Investigators. Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):377-388. doi: 10.1001/jama.2026.8142.
- Background: PubMed 41407860Guo L, Zhang B, Xue X, Zhang X, Cai H, Jiang H, Zhang L, Jin P, Wang X, Cheng Z, Zhang S, Geng J, Guo Y, Hu H, Ma Q, Li L, Du H, Han-Zhang H, Xue F, Deng H, Qian L, Yang W; DREAMS-2 investigators. Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes. Nature. 2026 Apr;652(8108):181-188. doi: 10.1038/s41586-025-10031-z. Epub 2025 Dec 17.
- Background: PubMed 41407859Zhu D, Zhao J, Cai H, Chu X, Xiu S, Song C, Cheng Z, Cao H, Jiang H, Zhang L, Wang H, Shi B, Li Y, Liu M, Feng B, Xue F, Deng H, Li H, Li L, Li Y, Ma Q, Qian L. Mazdutide versus placebo in Chinese adults with type 2 diabetes. Nature. 2026 Apr;652(8108):174-180. doi: 10.1038/s41586-025-10026-w. Epub 2025 Dec 17.
- Background: PubMed 40421736Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.
- Background: PubMed 41028652Shirley M. Mazdutide: First Approval. Drugs. 2025 Dec;85(12):1621-1627. doi: 10.1007/s40265-025-02249-y. Epub 2025 Sep 30.
- Background: PubMed 39794615Pasqua MR, Tsoukas MA, Kobayati A, Aboznadah W, Jafar A, Haidar A. Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial. Nat Med. 2025 Apr;31(4):1239-1245. doi: 10.1038/s41591-024-03463-z. Epub 2025 Jan 10.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) collected in this study available to researchers outside the primary research group. The study data will be kept confidential by the sponsor and investigators in accordance with applicable regulations and the study protocol. Sharing of IPD is not planned due to considerations regarding participant confidentiality and data protection.
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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 study testing Mazdutide and Placbo in people with Type 1 Diabetes, run by Peking University People's Hospital.
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 18 inclusion and 13 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 9 Nov 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. 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.
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 Chu Lin, M.D. (+86 18811792075, chulin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the participants achieving time in range (TIR)>70 and time below range (TBR)<4% (TIMES-EFFICACY) (time frame: From baseline to 16 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 NCT07924553, which also lists 6 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 9 Nov 2026.