An interventional study of Mazdutide and Placbo in Type 1 Diabetes, sponsored by Peking University People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 182 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with a clinical diagnosis of T1D for at least 12 months.
Patients with T1D must satisfy all three of the following features:
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:
Ability to provide prior to any study-related activity.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Mazdutide
Participants in the control group will receive a placebo matched to mazdutide in appearance, packaging, and mode of administration, by subcutaneous injection once weekly.
Drug: Placbo
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.
mazdutide matching placebo
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
Time frame: 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)
Time frame: From baseline to 52 weeks
Level of HbA1c
Changes in HbA1c (%) from baseline to Week 16 and Week 52
Time frame: 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
Time frame: From baseline to 52 weeks
Thickness of carotid intima-media
Changes in carotid intima-media thickness (cIMT) in mm from baseline to Week 52
Time frame: From baseline to 52 weeks
Time in range (TIR)
Changes in TIR (%) from baseline to Week 52
Time frame: From baseline to 52 weeks
Time above range (TAR)
Changes in TAR (%) from the baseline to Week 52
Time frame: From baseline to 52 weeks
Time below range (TBR)
Changes in TBR (%) from baseline to Week 52
Time frame: From baseline to 52 weeks
Covariation (CV)
Changes in CV (%) assessed by continuous glucose monitoring from baseline to Week 52
Time frame: From baseline to 52 weeks
Level of triglyceride (TG)
Changes in TG (mmol/L) from baseline to Week 52
Time frame: From baseline to 52 weeks
Level of total cholesterol (TC)
Changes in TC (mmol/L) from baseline to Week 52
Time frame: From baseline to 52 weeks
Level of low-density cholesterol (LDL-C)
Changes in LDL-C (mmol/L) from baseline to Week 52
Time frame: From baseline to 52 weeks
Level of high-density cholesterol (HDL-C)
Changes in HDL-C (mmol/L) from baseline to Week 52
Time frame: From baseline to 52 weeks
The level of urinary albumin/creatinine ratio
Changes in urinary albumin/creatinine ratio (mg/g) from baseline to Week 52
Time frame: From baseline to 52 weeks
Change in hepatic fat content
Changes in hepatic fat content (%) from baseline to Week 52, assessed by MRI-PDFF
Time frame: From baseline to 52 weeks
Levels of inflammation-related protein biomarkers
Changes in inflammation-related protein biomarkers (assessed by Olink) from baseline to Week 52
Time frame: From baseline to Week 52
No study locations are listed for this record.
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Mazdutide
Peking University People's Hospital →