A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity
Tirzepatide for Type 2 Diabetes and Obesity: A Phase 2 Trial
Plain English Summary
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity is a Phase 2 clinical trial sponsored by Eli Lilly and Company studying Type 2 Diabetes, Obesity. This study tests different doses of an investigational drug called tirzepatide. It is for adults with Type 2 diabetes and obesity who are already taking metformin. Participants will receive either tirzepatide or a placebo (inactive substance) by injection. Alternatives include other diabetes medications, weight loss programs, and lifestyle changes. The trial aims to enroll 414 participants.
Official Summary
The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with Type 2 diabetes and obesity. Must have a BMI of 35 or higher. Must be taking a stable dose of metformin for at least 90 days. Cannot have Type 1 diabetes, recent severe hypoglycemia, or certain heart/kidney conditions. This trial is studying Type 2 Diabetes, Obesity, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see how much tirzepatide can reduce body weight compared to a placebo, which could lead to better health outcomes for patients. The specific primary outcome measures are: Percent Change From Baseline in Body Weight (Baseline (Week 0), Week 44). 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 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial is important because it explores new treatment options for people with both Type 2 diabetes and obesity, addressing a significant unmet medical need. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Type 2 Diabetes, Obesity, where improved treatment options are needed.
Investor Insight
Eli Lilly and Company is sponsoring this trial, indicating a significant investment in developing tirzepatide for diabetes and obesity, a large and growing market. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for you, especially regarding your current diabetes and weight management. Participation involves regular injections and study visits for about 89 weeks. You will be monitored for side effects and your diabetes and weight will be tracked. 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: 414 participants
Interventions
- DRUG: Tirzepatide — Administered SC
- DRUG: Placebo — Administered SC
Primary Outcomes
- Percent Change From Baseline in Body Weight (Baseline (Week 0), Week 44)
Secondary Outcomes
- Change from Baseline in HbA1c (Baseline (Week 0), Week 44)
- Change from Baseline in HbA1c (Baseline (Week 24), Week 80)
- Percent Change from Baseline in Body Weight (Baseline (Week 24), Week 80)
- Absolute Change from Baseline in Body Weight (Baseline (Week 0), Week 44)
- Absolute Change from Baseline in Body Weight (Baseline (Week 24), Week 80)
Full Eligibility Criteria
Inclusion Criteria * Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening. * Have had stable body weight (±5%) during the 90 days preceding screening. * Have been diagnosed with Type 2 Diabetes (T2D). * Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day. Exclusion Criteria: * Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. * Have a prior or planned surgical treatment for obesity. * Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliter/min (mL/min)/1.73 m². * Have any of the following cardiovascular (CV) conditions within 2 months prior to screening. * acute myocardial infarction. * cerebrovascular accident (stroke). * unstable angina . * hospitalization due to congestive heart failure, or * coronary artery revascularization. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. * Have a history of chronic or acute pancreatitis.
Trial Locations
- Medical Advancement Centers of Arizona, Phoenix, Arizona, United States
- John Muir Physician Network Research Center, Concord, California, United States
- Care Access - Sacramento, Sacramento, California, United States
- Care Access - Aurora, Aurora, Colorado, United States
- Chase Medical Research, LLC, Waterbury, Connecticut, United States
- Retreat Medical Research, Miami, Florida, United States
- American Research Centers of Florida, Pembroke Pines, Florida, United States
- Alta Pharmaceutical Research Center, Norcross, Georgia, United States
- AGILE Clinical Research Trials, LLC, Sandy Springs, Georgia, United States
- Northwestern University, Chicago, Illinois, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06037252?
NCT06037252 is a Phase 2 INTERVENTIONAL study titled "A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity." It is currently active, not recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 414 participants.
What conditions does NCT06037252 study?
This trial investigates treatments for Type 2 Diabetes, Obesity. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT06037252?
The interventions being studied include: Tirzepatide (DRUG), Placebo (DRUG). Administered SC
What does Phase 2 mean for NCT06037252?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06037252?
This trial is currently "Active, Not Recruiting." It started on 2023-09-21. The estimated completion date is 2026-10.
Who is sponsoring NCT06037252?
NCT06037252 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 NCT06037252?
The trial aims to enroll 414 participants. The trial status is active, not recruiting.
How is NCT06037252 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 NCT06037252?
The primary outcome measures are: Percent Change From Baseline in Body Weight (Baseline (Week 0), Week 44). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06037252 being conducted?
This trial is being conducted at 20 sites, including Phoenix, Arizona; Concord, California; Sacramento, California; Aurora, Colorado and 16 more sites (United States).
Where can I find official information about NCT06037252?
The official record for NCT06037252 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06037252. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06037252 testing in simple terms?
This study tests different doses of an investigational drug called tirzepatide. It is for adults with Type 2 diabetes and obesity who are already taking metformin.
Why is this trial significant?
This trial is important because it explores new treatment options for people with both Type 2 diabetes and obesity, addressing a significant unmet medical need.
What are the potential risks of participating in NCT06037252?
Common side effects may include nausea, vomiting, diarrhea, and constipation. There is a risk of low blood sugar (hypoglycemia), especially when combined with other diabetes medications. Rare but serious risks include pancreatitis and allergic reactions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06037252?
Ask your doctor if this trial is a good fit for you, especially regarding your current diabetes and weight management. Participation involves regular injections and study visits for about 89 weeks. You will be monitored for side effects and your diabetes and weight will be tracked. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06037252 signal from an investment perspective?
Eli Lilly and Company is sponsoring this trial, indicating a significant investment in developing tirzepatide for diabetes and obesity, a large and growing market. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive either tirzepatide or a placebo (inactive substance) by injection. 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.