Retatrutide for Type 2 Diabetes and Obesity

(TRIUMPH-2 Trial)

Recruiting at 139 trial locations

Overseen By Joseph Soufer

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs, Stimulants

Disqualifiers: Type 1 diabetes, Thyroid carcinoma, Pancreatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 80 weeks

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing retatrutide, a medication for people with type 2 diabetes who are overweight or obese, including some with sleep apnea. The medication aims to help control blood sugar levels and may also aid in weight loss.

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 must be on stable treatment for Type 2 Diabetes for at least 90 days before joining. If you use certain medications like stimulants or hypnotics, you should have stopped them at least 3 months before the trial.

What data supports the effectiveness of the drug Retatrutide for type 2 diabetes and obesity?

Research shows that Retatrutide, which targets specific hormone receptors, effectively lowers blood sugar and body weight in people with type 2 diabetes. It also shows promise in managing obesity, similar to other treatments that target these hormone pathways. ^{1 2 3 4 5}

Is Retatrutide safe for humans?

Retatrutide has been studied for safety in people with obesity and type 2 diabetes, showing promise in managing these conditions. However, detailed safety data, including side effects, are still being evaluated in ongoing trials. ^{1 2 3 4 6}

What makes the drug Retatrutide unique for treating type 2 diabetes and obesity?

Retatrutide is unique because it targets three different receptors (GLP-1, GIP, and glucagon receptors) simultaneously, which helps lower blood sugar and reduce body weight, unlike many other treatments that typically target only one receptor. ^{1 2 3 4 7}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with Type 2 Diabetes and a BMI of at least 27, who have tried to lose weight unsuccessfully. Participants may also have moderate-to-severe obstructive sleep apnea (OSA) but should not be on certain OSA treatments or recent weight loss drugs. They mustn't have had significant weight changes recently or any history of specific thyroid cancers.

Inclusion Criteria

You have a moderate-to-severe obstructive sleep apnea, which is confirmed by a specific test called polysomnography.

I have used PAP therapy for 3 months and can stop it for 7 days before sleep studies.

You have tried to lose weight by changing your diet before, but it didn't work.

Exclusion Criteria

I have had pancreatitis.

I haven't used stimulants like modafinil or amphetamines in the last 3 months.

I have lost or gained more than 11 pounds in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive retatrutide or placebo subcutaneously

80 weeks

Up to 24 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-9 weeks

Treatment Details

Interventions

• Retatrutide

Trial Overview The study tests the effectiveness and safety of Retatrutide in people with Type 2 Diabetes who are overweight or obese, including some with OSA. It's an approximately 89-week study involving up to 24 visits, comparing Retatrutide against a placebo.

Participant Groups

Group I: Retatrutide Dose 3 Experimental Treatment 1 Intervention

Participants will receive retatrutide SC.

Group II: Retatrutide Dose 2 Experimental Treatment 1 Intervention

Participants will receive retatrutide SC.

Group III: Retatrutide Dose 1 Experimental Treatment 1 Intervention

Participants will receive retatrutide subcutaneously (SC).

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

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

Retatrutide, a triple agonist targeting incretin receptors, has shown significant weight loss and reductions in glycated hemoglobin (HbA1c) in phase-2 trials for individuals with type 2 diabetes mellitus (T2DM), as well as substantial weight loss in non-T2DM individuals, although gastrointestinal side effects were noted.

Concerns about cardiovascular safety have emerged due to dose-dependent increases in heart rate and mild to moderate cardiac arrhythmias, highlighting the need for long-term cardiovascular outcome trials to assess its safety in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retatrutide: a triple incretin receptor agonist for obesity management. Ray, A.[2023]

In a phase 2 trial with 338 adults, retatrutide significantly reduced body weight over 48 weeks, with the highest dose (12 mg) leading to an average weight loss of 24.2% compared to only 2.1% in the placebo group.

While retatrutide was effective, the most common side effects were gastrointestinal issues, which were generally mild to moderate and could be managed by starting with a lower dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. Jastreboff, AM., Kaplan, LM., Frías, JP., et al.[2023]

In a phase 2 trial involving 281 participants with type 2 diabetes, retatrutide demonstrated significant improvements in glycaemic control, with reductions in HbA1c levels that were greater than placebo and comparable to standard treatments like dulaglutide.

Retatrutide also led to substantial weight loss, with reductions of up to 16.94% at higher doses, while maintaining a safety profile similar to other GLP-1 receptor agonists, with no severe hypoglycaemia or deaths reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. Rosenstock, J., Frias, J., Jastreboff, AM., et al.[2023]

In a phase 2 clinical trial, retatrutide demonstrated significant weight loss in participants, with reductions ranging from -7.2% to -18% over 24 weeks, depending on the dosage (1 mg to 12 mg).

While retatrutide shows promise for treating obesity and type 2 diabetes, it also caused an increase in heart rate by up to 6.7 beats per minute, which could be a concern and may counteract some benefits of weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retatrutide showing promise in obesity (and type 2 diabetes). Doggrell, SA.[2023]

In a study involving approximately 32,800 users of exenatide, there was a modestly higher incidence of claims for thyroid malignancies compared to users of metformin or glyburide, but this association was not significant when focusing on inpatient claims.

Exenatide use was not linked to an increased risk of benign thyroid neoplasms or pancreatic cancer, suggesting it may be a safe option regarding these specific cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Dore, DD., Seeger, JD., Chan, KA.[2021]

References

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

Retatrutide: a triple incretin receptor agonist for obesity management. [2023]

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

Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. [2023]

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

Retatrutide showing promise in obesity (and type 2 diabetes). [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

Incretin-based therapy of metabolic disease. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. [2021]

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

Diabesity: therapeutic options. [2022]