Eloralintide + Tirzepatide for Obesity

Recruiting at 2 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: GLP-1 RAs, Weight loss medications

Disqualifiers: Diabetes, Malignancy, GI disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 11-26 weeks

188 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken weight loss medications in the last 3 months or plan to use them during the study.

What data supports the effectiveness of the drug Eloralintide + Tirzepatide for obesity?

Research shows that tirzepatide, one of the drugs in the combination, significantly helps with weight loss in people with obesity, both with and without type 2 diabetes. In studies, people taking tirzepatide lost a substantial amount of weight compared to those who did not take it. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been shown to be generally safe in humans, with mild to moderate and temporary stomach-related side effects being the most common. It has been tested in people with type 2 diabetes and obesity, showing a low risk of causing low blood sugar. ^{1 6 7 8 9}

How does the drug Eloralintide + Tirzepatide differ from other obesity treatments?

The combination of Eloralintide and Tirzepatide for obesity is unique because Tirzepatide is a dual-action drug that targets two hormone pathways to enhance weight loss, which is different from many existing treatments. Tirzepatide has shown significant weight reduction in clinical trials, and when combined with Eloralintide, it may offer a novel approach to managing obesity. ^{2 3 6 10 11}

What is the purpose of this trial?

The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it. There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.

Research Team

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for individuals with overweight or obesity who are interested in participating in a study to test the effects of two drugs, Eloralintide and Tirzepatide. Participants will receive these medications under their skin and must be willing to undergo blood tests.

Inclusion Criteria

Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive

Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening

Have had a stable weight for the 3 months prior to screening and enrollment, that is, less than 5% body weight change

Exclusion Criteria

Have known allergies to related compounds of eloralintide or tirzepatide, or any of the components of the formulations

I have had low or high calcium levels or abnormal blood phosphorus levels.

I plan to take weight loss medications during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous doses of Eloralintide and Tirzepatide or Eloralintide alone, with blood tests to evaluate pharmacokinetics

11-26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Eloralintide
• Eloralintide with Tirzepatide

Trial Overview The trial is testing how well people tolerate Eloralintide alone or combined with Tirzepatide, as well as the side effects that may occur. It involves multiple groups (cohorts) and lasts up to 26 weeks depending on the cohort.

Participant Groups

Group I: Eloralintide-Cohorts E and F Experimental Treatment 1 Intervention

Eloralintide administered SC

Group II: Eloralintide and Tirzepatide-Cohorts A-D Experimental Treatment 1 Intervention

Eloralintide and Tirzepatide administered subcutaneously (SC)

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

In a study of 579 adults with obesity, tirzepatide significantly enhanced weight loss after a 12-week lifestyle intervention, achieving an average additional weight reduction of 18.4% compared to just 2.5% with placebo over 72 weeks.

The treatment was well-tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating that tirzepatide is a safe and effective option for further weight management in individuals who have already lost weight through lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Wadden, TA., Chao, AM., Machineni, S., et al.[2023]

Tirzepatide, administered once weekly, has been shown to be effective in promoting weight loss in individuals with obesity, as demonstrated in a clinical study.

The treatment not only aids in weight reduction but also improves metabolic health markers, making it a promising option for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[2022]

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., et al.[2023]

Tirzepatide significantly improved quality of life (QoL) and treatment satisfaction in patients with type 2 diabetes across five clinical trials, with higher doses leading to greater improvements.

The improvements in QoL were measured using various patient-reported outcomes over 40 to 52 weeks, indicating that tirzepatide is effective not only for glycemic control but also for enhancing overall well-being in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Boye, KS., Thieu, VT., Sapin, H., et al.[2023]

In a 72-week phase 3 trial involving 2539 adults with obesity, tirzepatide (5 mg, 10 mg, or 15 mg) resulted in significant weight loss, with mean reductions of -15.0%, -19.5%, and -20.9% respectively, compared to only -3.1% with placebo.

A high percentage of participants (85% to 91%) on tirzepatide achieved at least a 5% weight reduction, and many experienced improvements in cardiometabolic measures, although gastrointestinal side effects were the most common adverse events, mostly mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. Jastreboff, AM., Aronne, LJ., Ahmad, NN., et al.[2023]

Tirzepatide, a dual-action drug for type 2 diabetes, has shown significant improvements in glycemic control and weight loss (between -6.2 to -12.9 kg) in phase 3 clinical trials, making it more effective than other diabetes medications.

The drug is well tolerated with a low risk of hypoglycemia and has demonstrated cardiovascular benefits, including improved lipid profiles and reduced blood pressure, with ongoing studies expected to provide further insights into its safety and potential uses in obesity and heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A Promising Drug for Type 2 Diabetes and Beyond. Dutta, P., Kumar, Y., Babu, AT., et al.[2023]

Tirzepatide, a novel GLP-1 receptor agonist, has been shown to significantly reduce A1C levels and body weight in patients with type 2 diabetes compared to placebo and other active treatments.

The safety profile of tirzepatide is similar to other GLP-1 receptor agonists, with the most common side effects being mild to moderate gastrointestinal issues, and it does not increase the risk of hypoglycemia, making it a promising treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. Kushner, P., Anderson, JE., Simon, J., et al.[2023]

Tirzepatide, a dual receptor agonist for type 2 diabetes, significantly reduces body weight compared to placebo, with an average weight loss of up to 11.8 kg and a percent change in weight of up to -12.4% over 12 to 72 weeks in a meta-analysis of 6 studies involving 4036 participants.

While tirzepatide is effective for weight management, it is associated with a higher incidence of gastrointestinal side effects, such as nausea, vomiting, and diarrhea, particularly at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dual GIP and GLP-1 receptor agonist tirzepatide for weight loss: a meta-analysis of randomized controlled trials. de Mesquita, YLL., Pera Calvi, I., Reis Marques, I., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A phase 1 multiple-ascending dose study of tirzepatide in Japanese participants with type 2 diabetes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide: A Promising Drug for Type 2 Diabetes and Beyond. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dual GIP and GLP-1 receptor agonist tirzepatide for weight loss: a meta-analysis of randomized controlled trials. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Tirzepatide for the treatment of adults with type 2 diabetes: An endocrine perspective. [2023]