A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight
Tirzepatide Trial for Type 1 Diabetes and Obesity: Phase 3 Study
Plain English Summary
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight is a Phase 3 clinical trial sponsored by Eli Lilly and Company studying Type 1 Diabetes, Obesity, Overweight. This study tests if tirzepatide, a medication, is effective and safe for adults with Type 1 Diabetes who are also obese or overweight. It is for adults diagnosed with Type 1 Diabetes who are also managing obesity or being overweight. Participants will receive either tirzepatide or a placebo injection weekly for about 49 weeks, with regular check-ups. Current alternatives focus on insulin management and lifestyle changes; this trial explores a new medication option. The trial aims to enroll 905 participants.
Official Summary
The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with Type 1 Diabetes for at least one year. Individuals with a BMI of 25 or higher and an HbA1c between 7.0% and 10.5%. Those who have not had recent hospitalizations for high blood sugar or severe low blood sugar. People who have not had pancreatitis or are not currently receiving treatment for diabetic eye disease. This trial is studying Type 1 Diabetes, Obesity, Overweight, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well tirzepatide lowers HbA1c, a key indicator of long-term blood sugar control, meaning it aims to help patients better manage their diabetes. The specific primary outcome measures are: Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a significant unmet need by investigating a new treatment option for individuals with Type 1 Diabetes who also struggle with obesity, aiming to improve both blood sugar control an As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Type 1 Diabetes, Obesity, Overweight, where improved treatment options are needed.
Investor Insight
This Phase 3 trial for tirzepatide in Type 1 Diabetes with obesity signals strong investor confidence in a drug already approved for Type 2 Diabetes, targeting a large patient population with signific Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 905 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of tirzepatide, and if this study is a good fit for your health. Participation involves weekly injections, regular blood tests, and glucose monitoring for approximately 49 weeks. You will need to maintain your current weight and avoid starting new intensive diet or exercise programs during the study. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 905 participants
Interventions
- DRUG: Tirzepatide — Administered SC
- DRUG: Placebo — Administered SC
Primary Outcomes
- Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40)
Secondary Outcomes
- Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L) Inclusive, Per Day (Within 30 days prior to Week 40)
- Change from Baseline in Body Weight (Baseline, Week 40)
- Percent Change from Baseline in Body Weight (Baseline, Week 40)
- Percentage of Participants with ≥5% Body Weight Reduction (Baseline, Week 40)
- Percentage of Participants with ≥10% Body Weight Reduction (Baseline, Week 40)
Full Eligibility Criteria
Inclusion Criteria: * Have type 1 diabetes and on insulin treatment for at least one year prior to screening * Have an HbA1c value of 7.0% to 10.5% inclusive, at screening * Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening * Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study Exclusion Criteria: * Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization. * Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have had chronic or acute pancreatitis * Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
Trial Locations
- Sansum Diabetes Research Institute, Santa Barbara, California, United States
- Care Access - Santa Clarita, Santa Clarita, California, United States
- University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
- Atlanta Diabetes Associates, Atlanta, Georgia, United States
- Orita Clinical Research, Decatur, Georgia, United States
- North Georgia Clinical Research, Woodstock, Georgia, United States
- East-West Medical Research Institute, Honolulu, Hawaii, United States
- Rocky Mountain Clinical Research, Idaho Falls, Idaho, United States
- Southern Illinois University School of Medicine, Springfield, Illinois, United States
- Indiana University Health University Hospital, Indianapolis, Indiana, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06914895?
NCT06914895 is a Phase 3 INTERVENTIONAL study titled "A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight." It is currently active, not recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 905 participants.
What conditions does NCT06914895 study?
This trial investigates treatments for Type 1 Diabetes, Obesity, Overweight. The primary condition under study is Type 1 Diabetes.
What treatments are being tested in NCT06914895?
The interventions being studied include: Tirzepatide (DRUG), Placebo (DRUG). Administered SC
What does Phase 3 mean for NCT06914895?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06914895?
This trial is currently "Active, Not Recruiting." It started on 2025-04-25. The estimated completion date is 2026-12.
Who is sponsoring NCT06914895?
NCT06914895 is sponsored by Eli Lilly and Company. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06914895?
The trial aims to enroll 905 participants. The trial status is active, not recruiting.
How is NCT06914895 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06914895?
The primary outcome measures are: Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06914895 being conducted?
This trial is being conducted at 20 sites, including Santa Barbara, California; Santa Clarita, California; Aurora, Colorado; Atlanta, Georgia and 16 more sites (United States).
Where can I find official information about NCT06914895?
The official record for NCT06914895 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06914895. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06914895 testing in simple terms?
This study tests if tirzepatide, a medication, is effective and safe for adults with Type 1 Diabetes who are also obese or overweight. It is for adults diagnosed with Type 1 Diabetes who are also managing obesity or being overweight.
Why is this trial significant?
This trial addresses a significant unmet need by investigating a new treatment option for individuals with Type 1 Diabetes who also struggle with obesity, aiming to improve both blood sugar control an As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06914895?
Common side effects may include nausea, vomiting, diarrhea, and decreased appetite, which are often mild to moderate. There is a risk of severe hypoglycemia (very low blood sugar), especially when used with insulin. Potential serious risks include pancreatitis and diabetic ketoacidosis (DKA), though these are less common. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06914895?
Ask your doctor about the potential benefits and risks of tirzepatide, and if this study is a good fit for your health. Participation involves weekly injections, regular blood tests, and glucose monitoring for approximately 49 weeks. You will need to maintain your current weight and avoid starting new intensive diet or exercise programs during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06914895 signal from an investment perspective?
This Phase 3 trial for tirzepatide in Type 1 Diabetes with obesity signals strong investor confidence in a drug already approved for Type 2 Diabetes, targeting a large patient population with signific This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either tirzepatide or a placebo injection weekly for about 49 weeks, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.