Overview
Eli Lilly has shared positive results from two more Phase 3 Retatrutide trials. Participants lost up to 22.6% of their body weight, blood sugar improved in people with type 2 diabetes, and the company now plans to submit the drug for FDA approval in early 2027.
Another Win for Retatrutide: What Eli Lilly Just Revealed
Last year, Retatrutide caught everyone’s attention after producing some of the biggest weight-loss results ever seen in a clinical trial.
Many people wondered whether those early results would hold up in larger studies.
Now we have more answers.
Eli Lilly has released topline results from two more Phase 3 clinical trials. Both studies met their main goals. More importantly, the results look very similar to what researchers had hoped to see.
People lost a significant amount of weight. Blood sugar also improved in participants living with type 2 diabetes. Based on these results, Lilly says it plans to submit Retatrutide for FDA approval in early 2027.
So, what exactly did these studies find?
What Is Retatrutide?
Retatrutide is an experimental obesity drug being developed by Eli Lilly.
What makes it different is that it doesn’t work on just one hormone.
Instead, it activates three different receptors:
- GLP-1
- GIP
- Glucagon
Researchers believe this combination may help people eat less, burn more energy, and better control their blood sugar at the same time.
That is one reason why Retatrutide has become one of the most talked-about obesity drugs still in development.
Two More Phase 3 Trials Have Reported Positive Results
The new data come from two studies called TRIUMPH-2 and TRIUMPH-3.
Together, they included adults living with obesity, although each study looked at a different group of patients.
Both trials lasted 80 weeks.
At the end of the studies, Retatrutide met its primary goal in both trials by helping participants lose significantly more weight than those receiving a placebo.
Let’s look at each study separately.
TRIUMPH-2: Adults With Type 2 Diabetes
The first study included adults living with obesity or overweight who also had type 2 diabetes.
This is an important group because losing weight is often more difficult for people with diabetes.
Even so, the results were impressive.
People taking the highest dose of Retatrutide lost an average of 20.8% of their body weight.
Researchers also reported that HbA1c, a measure of long-term blood sugar, dropped by about 1.6 percentage points.
In simple words, participants didn’t just lose weight. Their diabetes control also improved.
| Retatrutide Dose | Average Weight Loss | Percentage of Body Weight Lost |
|---|---|---|
| 4 mg | 29.8 lbs | 12.7% |
| 9 mg | 45.4 lbs | 19.1% |
| 12 mg | 49.6 lbs | 20.8% |
TRIUMPH-3: People Living With Cardiovascular Disease
The second Phase 3 study looked at a different group of people.
This time, researchers enrolled adults living with obesity who also had established cardiovascular disease. These are people who are generally at a higher risk of serious health complications.
Once again, Retatrutide delivered strong results.
Participants taking the highest dose lost an average of 22.6% of their body weight after 80 weeks of treatment.
Researchers also saw improvements in several important health markers. These included blood pressure, waist circumference, and blood lipid levels.
The study wasn’t designed to prove that Retatrutide reduces the risk of heart attacks or strokes. More research will be needed to answer that question.
Still, these findings are encouraging. Losing a significant amount of weight while improving overall metabolic health could make a real difference for people living with obesity and cardiovascular disease.
| TRIUMPH-3 Highlights | Results |
|---|---|
| Study Population | Adults with severe obesity and established cardiovascular disease (with or without type 2 diabetes) |
| Retatrutide Doses | 9 mg and 12 mg |
| Study Duration | 80 weeks |
| Maximum Average Weight Loss | 55.8 lbs (22.6%) |
| Triglyceride Reduction | 37.0% |
| Non-HDL Cholesterol Reduction | 16.5% |
| Systolic Blood Pressure Reduction | 9.3 mmHg |
| Waist Circumference Reduction | 7.5 in (19.0 cm) |
| hsCRP Reduction | 51.2% |
Was Retatrutide Safe?
No medication is completely free of side effects, and Retatrutide was no exception.
The good news is that the safety results looked very similar to what researchers had seen in earlier studies.
Most of the reported side effects were related to the digestive system.
The most common ones included:
- Nausea
- Diarrhoea
- Vomiting
These side effects are also commonly seen with other GLP-1-based weight-loss medications. In most cases, they happened while the dose was being increased and became easier to manage over time.
Overall, Lilly said the safety profile was consistent with previous Retatrutide trials.
Why Do These Results Matter?
Retatrutide has been making headlines for more than a year. Earlier studies showed that it could help people lose a significant amount of weight.
The big question was whether those results would hold up in larger Phase 3 trials.
So far, the answer appears to be yes.
Both TRIUMPH-2 and TRIUMPH-3 met their main goals. More importantly, the amount of weight loss remained consistent with what researchers had seen in earlier studies.
For people living with obesity, this is encouraging news. It suggests that Retatrutide may continue to deliver meaningful weight loss across different groups of patients, including those with type 2 diabetes and cardiovascular disease.
Of course, these are still clinical trial results. The FDA will carefully review all of the available data before deciding whether the treatment should be approved.
What’s Next for Retatrutide?
After announcing these positive Phase 3 results, Eli Lilly said it plans to submit its application to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027.
If the FDA accepts the application, Retatrutide will move into the formal review process. That review will determine whether the drug can be approved for chronic weight management in the United States.
Lilly is also continuing several other Phase 3 studies to better understand how Retatrutide performs in different patient populations and obesity-related conditions.
