Tirzepatide

NCT07284511 · RECRUITING

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose. Tirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises. This study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups: Tirzepatide group: Participants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals. Control group: Participants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses. The main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart/fitness, or body-composition tests. As with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial. Overall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.

Outcomes: Daytime Time-in-Range · Weight · Height · Body Mass Index · Waist circumference · Waist-to-Hip Ratio · Systolic Blood Pressure · Diastolic Blood Pressure · Resting Heart Rate · Insulin-related measures · Glucose outcomes · Glycated Hemoglobin (HbA1c) · Estimated Glomerular Filtration Rate · Serum Creatinine · Albumin-to-Creatinine Ratio · Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides) · Liver Function Markers (Alanine transaminase, Alkaline phosphatase) · Liver Function Markers (Bilirubin) · Cardiac Biomarkers (NT-proBNP) · Inflammatory Biomarkers (hs-CRP)

NCT05536804 · ACTIVE_NOT_RECRUITING

A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D). The study will last about 56 weeks and include up to 12 visits.

Outcomes: Percent Change from Baseline in Renal Sinus Fat Content (MRI) · Percent Change from Baseline in Body Weight · Percent Change from Baseline in Renal Fat Content (MRI Proton Density Fat Fraction) · Percent Change from Baseline in Renal Blood Flow (Phase-Contrast MRI) · Change from Baseline in Apparent Diffusion Coefficient (ADC) MRI · Change from Baseline in Glomerular Filtration Rate (GFR) Iohexol Clearance in Milliliter/Minute/Square Meter (ml/min/m²) · Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) · Change from Baseline in 24-hour Urinary Albumin Excretion (UAE) in Milligram/24 Hours (mg/24h) · Percent Change from Baseline in Urine Albumin-to-Creatine Ratio (UACR) in Participants With Baseline ≥30 mg/g

NCT07567378 · NOT_YET_RECRUITING

CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry

CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1/GIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \<1.0 kg/m² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP/GLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready

Outcomes: ACR20 response rate at Week 4 in the Mechanistic Analysis Set · Proportion of Week-4 ACR20 response mediated by biomarker panel in the Mechanistic Analysis Set · Change in knee cartilage T2 relaxation time from Week 0 to Week 52 · Change in epicardial adipose tissue volume from Week 0 to Week 52 · Change in epicardial adipose tissue mean attenuation from Week 0 to Week 52 · Change in epicardial adipose tissue radiomic texture composite z-score from Week 0 to Week 52 · Longitudinal visceral adipose tissue trajectory over six timepoints · Longitudinal phase-angle trajectory (aging biomarker) over six timepoints · HLA-stratified articular and cardiac response · Change in Leeds Enthesitis Index (LEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup · Change in Madrid Sonographic Enthesitis Index (MASEI) from Week 0 to Week 52 in the psoriatic arthritis subgroup · Transcriptomic signature of epicardial adipose tissue in tirzepatide-exposed participants undergoing cardiac surgery · Longitudinal biomarker panel trajectories · Change in modified Nail Psoriasis Severity Index (mNAPSI) from Week 0 to Week 52 in the psoriatic arthritis subgroup

NCT05822544 · ACTIVE_NOT_RECRUITING

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.

Outcomes: Incidence of TLC-6740 treatment-emergent adverse events · PK of TLC-6740 AUC · PK of TLC-6740 Cmax · PK of TLC-6740 tmax · PK of TLC-6740 t1/2 · PK of TLC-6740 CL/F

NCT03882970 · COMPLETED

A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.

Outcomes: Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) · Change From Baseline in HbA1c (5 mg) · Change From Baseline in Body Weight · Change From Baseline in Fasting Serum Glucose · Percentage of Participants Achieving an HbA1c Target Value of <7% · Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values · Percentage of Participants Who Achieved Weight Loss ≥5% · Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score · Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia

Results summary: {"participantFlowModule":{"groups":[{"id":"FG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"FG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"FG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"FG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\ 99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.","pValue":" 99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.","pValue":" 99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.","pValue":" 8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as covariates.","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\ 8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per Deciliter (mg/dL)","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","description":"Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.\n\nThe starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) \\ 8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week SC."},{"id":"OG003","title":"Insulin Degludec","descripti

NCT02759107 · COMPLETED

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

The main purposes of this study are to determine: * The safety of tirzepatide and any side effects that might be associated with it. * How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it. * How tirzepatide affects the levels of blood sugar. This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in duration, including screening. Each participant will enroll in only one part. This study is for research purposes only, and is not intended to treat any medical condition.

Outcomes: Number of Participants With One or More Serious Adverse Event(s) (SAEs) · Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. · Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B · Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C · Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C) · Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)

Results summary: {"participantFlowModule":{"groups":[{"id":"FG000","title":"Part A Placebo","description":"Participants received placebo by subcutaneous (SC) injection."},{"id":"FG001","title":"Part A 0.25 mg Tirzepatide","description":"Participants received single dose of 0.25 milligram (mg) Tirzepatide by subcutaneous injection."},{"id":"FG002","title":"Part A 0.5mg Tirzepatide","description":"Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection."},{"id":"FG003","title":"Part A 1mg Tirzepatide","description":"Participants received single dose of 1mg Tirzepatide by subcutaneous injection."},{"id":"FG004","title":"Part A 2.5mg Tirzepatide","description":"Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection."},{"id":"FG005","title":"Part A 5mg Tirzepatide","description":"Participants received single dose of 5mg Tirzepatide by subcutaneous injection."},{"id":"FG006","title":"Part A 8mg Tirzepatide","description":"Participants received single dose of 8mg Tirzepatide by subcutaneous injection."},{"id":"FG007","title":"Part B Placebo","description":"Participants received placebo by subcutaneous injection."},{"id":"FG008","title":"Part B 1.5mg Dulaglutide","description":"Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection."},{"id":"FG009","title":"Part B 0.5mg Tirzepatide","description":"Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG010","title":"Part B 1.5mg Tirzepatide","description":"Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG011","title":"Part B 4.5mg Tirzepatide","description":"Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections."},{"id":"FG012","title":"Part B 5, 5, 8,10mg Tirzepatide","description":"Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW."},{"id":"FG013","title":"Part C Placebo","description":"Participants received placebo by subcutaneous injection."},{"id":"FG014","title":"Part C 0.5mg Tirzepatide","description":"Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG015","title":"Part C 5mg Tirzepatide","description":"Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection."},{"id":"FG016","title":"Part C 5, 5, 10,10mg Tirzepatide","description":"Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW."},{"id":"FG017","title":"Part C 5, 5, 10,15mg Tirzepatide","description":"Participants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"7"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"4"},{"groupId":"FG009","numSubjects":"6"},{"groupId":"FG010","numSubjects":"6"},{"groupId":"FG011","numSubjects":"6"},{"groupId":"FG012","numSubjects":"7"},{"groupId":"FG013","numSubjects":"11"},{"groupId":"FG014","numSubjects":"9"},{"groupId":"FG015","numSubjects":"9"},{"groupId":"FG016","numSubjects":"12"},{"groupId":"FG017","numSubjects":"12"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"7"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"4"},{"groupId":"FG009","numSubjects":"6"},{"groupId":"FG010","numSubjects":"6"},{"groupId":"FG011","numSubjects":"6"},{"groupId":"FG012","numSubjects":"7"},{"groupId":"FG013","numSubjects":"11"},{"groupId":"FG014","numSubjects":"9"},{"groupId":"FG015","numSubjects":"9"},{"groupId":"FG016","numSubjects":"12"},{"groupId":"FG017","numSubjects":"12"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"6"},{"groupId":"FG006","numSubjects":"7"},{"groupId":"FG007","numSubjects":"4"},{"groupId":"FG008","numSubjects":"4"},{"groupId":"FG009","numSubjects":"5"},{"groupId":"FG010","numSubjects":"6"},{"groupId":"FG011","numSubjects":"6"},{"gr