Efficacy, Safety and Cardiovascular Protection of Mazdutide in Type 1 Diabetes
NCT07924553, Not applicable, Not yet recruiting, Peking University People's Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy, Safety and Cardiovascular Protection of Mazdutide in Type 1 Diabetes | ClinicalTrials.gov |
| NCT number | NCT07924553 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 182 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Peking University People's Hospital | ClinicalTrials.gov |
| Conditions | Type 1 Diabetes | ClinicalTrials.gov |
| Interventions | Mazdutide, Placbo | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of the participants achieving time in range (TIR)>70 and time below range (TBR)<4% (TIMES-EFFICACY) | 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 | ClinicalTrials.gov |
| Primary | Volume of non-calcified coronary artery plaque (TIMES-CV) | 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) | ClinicalTrials.gov |
| Secondary | Level of HbA1c | From baseline to 52 weeks | Changes in HbA1c (%) from baseline to Week 16 and Week 52 | ClinicalTrials.gov |
| Secondary | Volume of coronary atherosclerotic plaque | From baseline to 52 weeks | Changes in total coronary atherosclerotic plaque volume, fibrous plaque volume, low-density plaque volume, and lipid-rich plaque volume in mm³ | ClinicalTrials.gov |
| Secondary | Thickness of carotid intima-media | From baseline to 52 weeks | Changes in carotid intima-media thickness (cIMT) in mm from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Time in range (TIR) | From baseline to 52 weeks | Changes in TIR (%) from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Time above range (TAR) | From baseline to 52 weeks | Changes in TAR (%) from the baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Time below range (TBR) | From baseline to 52 weeks | Changes in TBR (%) from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Covariation (CV) | From baseline to 52 weeks | Changes in CV (%) assessed by continuous glucose monitoring from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Level of triglyceride (TG) | From baseline to 52 weeks | Changes in TG (mmol/L) from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Level of total cholesterol (TC) | From baseline to 52 weeks | Changes in TC (mmol/L) from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Level of low-density cholesterol (LDL-C) | From baseline to 52 weeks | Changes in LDL-C (mmol/L) from baseline to Week 52 | ClinicalTrials.gov |
| Secondary | Level of high-density cholesterol (HDL-C) | From baseline to 52 weeks | Changes in HDL-C (mmol/L) from baseline to Week 52 | ClinicalTrials.gov |
| Other | The level of urinary albumin/creatinine ratio | From baseline to 52 weeks | Changes in urinary albumin/creatinine ratio (mg/g) from baseline to Week 52 | ClinicalTrials.gov |
| Other | Change in hepatic fat content | From baseline to 52 weeks | Changes in hepatic fat content (%) from baseline to Week 52, assessed by MRI-PDFF | ClinicalTrials.gov |
| Other | Levels of inflammation-related protein biomarkers | From baseline to Week 52 | Changes in inflammation-related protein biomarkers (assessed by Olink) from baseline to Week 52 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)