Eloralintide + Tirzepatide for Obesity

Not currently recruiting at 2 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the tolerance of two treatments—eloralintide alone and eloralintide with tirzepatide—in individuals who are overweight or have obesity. Researchers will monitor side effects and assess how the body processes these treatments when administered subcutaneously. The study seeks participants with a BMI between 27 and 40 who have maintained a stable weight over the past three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both eloralintide and its combination with tirzepatide may help treat obesity. When tested alone, eloralintide was generally well-tolerated in earlier studies. Participants lost a significant amount of weight, and few serious problems occurred. The main side effect was mild nausea, which was usually easy to manage.

Less specific information exists about the safety of combining eloralintide with tirzepatide from earlier studies. However, tirzepatide is already approved for other uses and is generally considered safe. The most common side effects of tirzepatide are stomach-related issues like nausea and diarrhea, which usually improve over time.

In summary, early studies suggest that both eloralintide alone and with tirzepatide are generally well-tolerated, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Eloralintide and Tirzepatide for obesity because these treatments offer unique approaches compared to current options like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Eloralintide uses a novel peptide that targets specific pathways in the brain to help control appetite, offering a new mechanism of action. When combined with Tirzepatide, which is a dual GLP-1 and GIP receptor agonist, the treatment may enhance weight loss by tackling multiple hormonal pathways simultaneously. This innovative combination aims to improve effectiveness and safety, potentially leading to better outcomes for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that eloralintide may aid in weight loss. In earlier studies, participants using eloralintide lost between 9% and 20% of their weight over 48 weeks, significantly more than those taking a placebo, which contains no active ingredients. Eloralintide affects a part of the brain that controls hunger and food intake. In this trial, some participants will receive eloralintide alone, while others will receive a combination of eloralintide and tirzepatide. The combination with tirzepatide, another medication, may enhance weight loss effects, as tirzepatide works in several ways to manage weight. These early findings suggest that this combination could be effective for individuals dealing with obesity. ^{1 2 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)02155-5/abstract

Eloralintide, a selective amylin receptor agonist for the ... Eloralintide produced clinically meaningful, dose-dependent reductions in bodyweight over 48 weeks and was generally well tolerated, supporting ...

2. lilly.gcs-web.com lilly.gcs-web.com/news-releases/news-release-details/lillys-selective-amylin-agonist-eloralintide-demonstrated

Lilly's selective amylin agonist, eloralintide, demonstrated ... At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% ...

3. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/eli-lilly-trial-eloralintide-weight-reduction-adults-obesity

Eli Lilly's Phase II Trial of Eloralintide Shows Up to 20% ... Mean weight loss ranged from 9% at the lowest dose to 20% at 9 mg after 48 weeks. Placebo group saw a 0.4% mean reduction in body weight.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625021555

Articles Eloralintide, a selective amylin receptor agonist for ... At 68 weeks, cagrilintide monotherapy provided an approximately 12% mean bodyweight loss. Eloralintide is a long-acting selective amylin ...

5. healio.com healio.com/news/endocrinology/20251106/novel-amylin-receptor-agonist-induces-clinically-meaningful-weight-loss

Novel amylin receptor agonist induces 'clinically ... Weight loss of 20% or more was achieved by 57% of the 9 mg eloralintide group and by 50% of those who received 6 mg eloralintide followed by 9 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41109426/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1Jgu41lFGSj_ShZE4NRQ2hnLFGqOVFuKpoCzfmgi2UmEsRik-&fc=None&ff=20251027222541&v=2.18.0.post22+67771e2

Eloralintide (LY3841136), a novel amylin receptor agonist ... Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept · Abstract.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06916091

NCT06916091 | A Study of Eloralintide (LY3841136) in ... The purpose of this study is to evaluate how well Eloralintide (LY3841136) is tolerated and what side effects may occur in overweight and obese Chinese ...