Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Verified Trial
Recruiting
Sponsor: Eli Lilly and Company
Prior Safety Data
Approved in 6 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Is the drug Tirzepatide a promising treatment for Type 2 Diabetes and Obesity?Yes, Tirzepatide is a promising drug for Type 2 Diabetes and Obesity. It helps control blood sugar levels and leads to significant weight loss. It also improves heart health by reducing fat, blood pressure, and improving insulin sensitivity. Many patients experience better results with Tirzepatide compared to other treatments.12378
What safety data is available for tirzepatide?Tirzepatide, a dual GIP/GLP-1 receptor agonist, has been evaluated in several clinical trials (SURPASS 1-5) for type 2 diabetes. Common adverse events include nausea, vomiting, diarrhea, and constipation, especially at higher doses. Cardiovascular events were monitored, showing a tendency to reduce MACE-4 events (nonfatal myocardial infarction, non-fatal stroke, cardiovascular death, and hospital admission for angina) over two years, with no hazard ratio greater than 1.0 compared to pooled comparators. The upper bounds of confidence intervals for MACE were less than 1.3, indicating cardiovascular safety. Overall, tirzepatide has shown a safety profile similar to selective GLP-1 receptor agonists.12456
What data supports the idea that Tirzepatide for Type 2 Diabetes and Obesity is an effective drug?The available research shows that Tirzepatide is effective for treating type 2 diabetes and obesity. In clinical trials, it helped reduce blood sugar levels and body weight more than other treatments like semaglutide and insulin. For example, patients lost between 5.4 to 11.7 kg and a significant number reached normal blood sugar levels. It also improved how the body uses insulin better than some other drugs. While it can cause side effects like nausea and vomiting, these are similar to other treatments. Overall, Tirzepatide shows promising results for managing diabetes and obesity.12567
Do I have to stop taking my current medications for the trial?The trial requires participants to continue taking metformin, but it does not specify if you need to stop other medications. However, you cannot use weight loss products or treatments for diabetic retinopathy and macular edema.
Eligibility Criteria
This trial is for adults with Type 2 diabetes and obesity, specifically those with a BMI of 35 or higher who have maintained a stable weight and been on metformin treatment for at least 90 days. Participants should not have had significant weight changes recently.Inclusion Criteria
Are you currently taking Metformin only to manage your diabetes?
Exclusion Criteria
Have you ever had surgery for obesity, or do you plan to undergo surgery shortly?
Do you have a recent history of myocardial infarction, stroke, unstable angina, congestive heart failure, or coronary artery revascularization?
Do you have Type I Diabetes?
Are you currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema?
Have you recently used products intended for weight loss including prescription drugs, over the counter drugs or herbal preparations?
Treatment Details
The study tests the safety and effectiveness of different doses of an experimental drug called Tirzepatide in people taking metformin for Type 2 diabetes and obesity over approximately 89 weeks. Some participants will receive Tirzepatide, while others will get a placebo.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Tirzepatide High Dose 2Experimental Treatment1 Intervention
Participants will receive tirzepatide SC.
Group II: Tirzepatide High Dose 1Experimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group III: TirzepatideActive Control1 Intervention
Participants will receive tirzepatide SC.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Tirzepatide is already approved in United States, European Union, Canada, Australia, United States, United Kingdom for the following indications:
🇺🇸 Approved in United States as Mounjaro for:
- Type 2 diabetes
🇪🇺 Approved in European Union as Mounjaro for:
- Type 2 diabetes
🇨🇦 Approved in Canada as Mounjaro for:
- Type 2 diabetes
🇦🇺 Approved in Australia as Mounjaro for:
- Type 2 diabetes
🇺🇸 Approved in United States as Zepbound for:
- Weight loss
- Moderate to severe obstructive sleep apnea
🇬🇧 Approved in United Kingdom as Zepbound for:
- Weight loss
Find a clinic near you
Research locations nearbySelect from list below to view details:
Care Access - SacramentoSacramento, CA
Care Access - AuroraAurora, CO
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
References
Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]Tirzepatide is a novel dual glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) currently under review for marketing approval. Individual trials have assessed the clinical profile of tirzepatide vs different comparators. We conducted a systematic review and meta-analysis to assess the efficacy and safety of tirzepatide for type 2 diabetes.
Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]Tirzepatide is the first dual GIP/GLP-1 receptor co-agonist approved for the treatment of type 2 diabetes in the USA, Europe, and the UAE. Tirzepatide is an acylated peptide engineered to activate the GIP and GLP-1 receptors, key mediators of insulin secretion that are also expressed in regions of the brain that regulate food intake. Five clinical trials in type 2-diabetic subjects (SURPASS 1-5) have shown that tirzepatide at 5-15 mg per week reduces both HbA1c (1.24 to 2.58%) and body weight (5.4-11.7 kg) by amounts unprecedented for a single agent. A sizable proportion of patients (23.0 to 62.4%) reached an HbA1c of < 5.7% (which is the upper limit of the normal range indicating normoglycaemia), and 20.7 to 68.4% lost more than 10% of their baseline body weight. Tirzepatide was significantly more effective in reducing HbA1c and body weight than the selective GLP-1 RA semaglutide (1.0 mg per week), and titrated basal insulin. Adverse events related to tirzepatide were similar to what has been reported for selective GLP-1RA, mainly nausea, vomiting, diarrhoea, and constipation, that were more common at higher doses. Cardiovascular events have been adjudicated across the whole study program, and MACE-4 (nonfatal myocardial infarction, non-fatal stroke, cardiovascular death and hospital admission for angina) events tended to be reduced over up to a 2 year-period, albeit with low numbers of events. For none of the cardiovascular events analysed (MACE-4, or its components) was a hazard ratio > 1.0 vs. pooled comparators found in a meta-analysis covering the whole clinical trial program, and the upper bounds of the confidence intervals for MACE were < 1.3, fulfilling conventional definitions of cardiovascular safety. Tirzepatide was found to improve insulin sensitivity and insulin secretory responses to a greater extent than semaglutide, and this was associated with lower prandial insulin and glucagon concentrations. Both drugs caused similar reductions in appetite, although tirzepatide caused greater weight loss. While the clinical effects of tirzepatide have been very encouraging, important questions remain as to the mechanism of action. While GIP reduces food intake and body weight in rodents, these effects have not been demonstrated in humans. Moreover, it remains to be shown that GIPR agonism can improve insulin secretion in type 2 diabetic patients who have been noted in previous studies to be unresponsive to GIP. Certainly, the apparent advantage of tirzepatide, a dual incretin agonist, over GLP-1RA will spark renewed interest in the therapeutic potential of GIP in type 2 diabetes, obesity and related co-morbidities.
Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. [2023]Tirzepatide (mounjaro®) is a derivative of the human glucose-dependent insulinotropic polypeptide (GIP) hormone with a position-20 being modified with 1,20- eicosanedioic acid via a chemical linker. It acts as a glucagon-like peptide-1 (GLP-1) receptor and GIP receptor agonist. It has recently been approved by FDA as an adjunct therapy to exercise and diet to improve glycemic control in patients with type II diabetes mellitus (T2DM). It represents a new transforming paradigm in the management of T2DM. This mini-review will shed light on its different pharmacokinetic and pharmacodynamic aspects.
Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]The objective of this article was to review pharmacology, efficacy, safety, and place in therapy of tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.
Adverse Events Related to Tirzepatide. [2023]Tirzepatide is a dual glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved by the US Food and Drug Administration in May 2022 for patients with type 2 diabetes mellitus (T2DM).
Tirzepatide: Clinical review of the "twincretin" injectable. [2023]To provide an overview of the safety and efficacy, pharmacology, dosing, place in therapy, and clinical trials for tirzepatide, a novel glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist for treatment of type 2 diabetes.
Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]Tirzeptide is a novel glucagon-like peptide-1 receptor (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) drug, which shows good efficiency for weight loss. Therefore, we aim to investigate the efficacy and safety of tirzepatide for weight loss in type 2 diabetes mellitus (T2DM) and obesity patients in this meta-analysis study.
Perspectives on weight control in diabetes - Tirzepatide. [2023]Tirzepatide, a once-weekly glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist (GIP/GLP-1 RA) improves glycemic control. Besides improvement of glycemic control, tirzepatide treatment is associated with significantly more weight loss as compared to potent selective GLP-1 receptor agonists as well as other beneficial changes in cardio-metabolic parameters, such as reduced fat mass, blood pressure, improved insulin sensitivity, lipoprotein concentrations, and circulating metabolic profile in individuals with type 2 diabetes (T2D). Some of these changes are partially associated with weight reduction. We review here the putative mechanisms of GIP receptor agonism contributing to GLP-1 receptor agonism-induced weight loss and respective findings with GIP/GLP-1 RAs, including tirzepatide in T2D preclinical models and clinical studies. Subsequently, we summarize the clinical data on weight loss and related non-glycemic metabolic changes of tirzepatide in T2D. These findings suggest that the robust weight loss and associated changes are important contributors to the clinical profile of tirzepatide for the treatment of T2D diabetes and serve as the basis for further investigations including clinical outcomes.