What side effects are associated with this type of intervention?

Common treatments for obesity similar to Retatrutide, such as GLP-1 receptor agonists (e.g., liraglutide, exenatide), often cause gastrointestinal side effects like nausea, vomiting, and diarrhea. There are also concerns about the risk of pancreatitis and potential thyroid C cell tumors observed in rodent studies, though the relevance to humans is unclear. These treatments are not recommended for individuals with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia types 2A or 2B.

What prior FDA approvals exist?

Several GLP-1 receptor agonists have been approved by the FDA for the treatment of obesity. Liraglutide (Saxenda) was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. Semaglutide (Wegovy) is another GLP-1 receptor agonist approved for weight management in adults with obesity or overweight. These drugs work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, similar to the mechanism of action of Retatrutide.

What other types of research exist?

Promising alternatives to Retatrutide for obesity treatment include Semaglutide, Liraglutide, and Dulaglutide. These GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, similar to Retatrutide. Semaglutide, in particular, has shown significant weight loss benefits and is available in both injectable and oral forms. Additionally, Tirzepatide, a dual GIP and GLP-1 receptor agonist, is emerging as a novel option with promising results in weight reduction and glycemic control.

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GLP-1 Receptor Agonist

Retatrutide for Type 2 Diabetes and Obesity (TRIUMPH-2 Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)

Have Type 2 Diabetes (T2D)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 80

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects for Retatrutide aren't specified here, common side effects for diabetes medications can include nausea, vomiting, digestive issues, potential low blood sugar events, and sometimes injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have a body mass index (BMI) of 27.0 or higher.

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I have Type 2 Diabetes.

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I have been on a stable treatment for type 2 diabetes for at least 3 months.

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I have been diagnosed with obstructive sleep apnea.

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You have a score of 15 or higher on a sleep test, which means you have moderate-to-severe obstructive sleep apnea.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 80

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 80

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 80 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset

Percent Change from Baseline in Body Weight

Secondary study objectives

A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset

Change from Baseline in Body Mass Index (BMI)

Change from Baseline in Diastolic Blood Pressure (DBP)

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Retatrutide Dose 3Experimental Treatment1 Intervention

Participants will receive retatrutide SC.

Group II: Retatrutide Dose 2Experimental Treatment1 Intervention

Participants will receive retatrutide SC.

Group III: Retatrutide Dose 1Experimental Treatment1 Intervention

Participants will receive retatrutide subcutaneously (SC).

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as Retatrutide, are effective in treating obesity by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which together help regulate blood sugar levels and promote weight loss. Other treatments include orlistat, which reduces fat absorption in the intestines, and bariatric surgery, which restricts food intake and alters gut hormone levels. These mechanisms are important for obesity patients as they help customize treatment plans to individual metabolic profiles, thereby increasing the chances of successful weight management.