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The phase III TRIUMPH-2 trial found that adults with obesity and type 2 diabetes taking retatrutide lost an average of 11.9% to 18.8% of their body weight by week 80, depending on dose, compared with 5.1% on placebo. The investigational drug also improved blood sugar measures; gastrointestinal events were common, and Eli Lilly plans to submit data to the FDA in early 2027.
Retatrutide, an investigational drug, produced average weight loss of 11.9% to 18.8% after 80 weeks in adults with obesity and type 2 diabetes, according to results from the phase III TRIUMPH-2 trial. The findings, presented at the European Association for the Study of Diabetes annual meeting and published in The Lancet, also showed improved blood sugar measures compared with placebo. Read more about weight loss seen with a combination drug in a diabetes trial.
Among 1,152 participants, average weight loss at week 80 was 11.9% (28.4 pounds) with the 4-mg dose, 16.8% (40.3 pounds) with 9 mg and 18.8% (45.6 pounds) with 12 mg. Participants receiving placebo lost an average of 5.1% (12.8 pounds). These figures use the treatment-regimen estimand, which accounts for outcomes under the trial’s treatment regimen.
In a separate efficacy estimand, which assumes participants took study medication as intended and excludes certain events that could affect interpretation, weight loss reached 20.8% with the 12-mg dose. Juan P. Frias, who presented the results, said that in this analysis more than half of patients lost over 15% of their body weight. That figure should not be confused with the treatment-regimen estimate, which was 18.8% for the same dose.
Retatrutide also lowered HbA1c, a measure of average blood sugar. Mean changes from baseline were -1.38% to -1.50% across the three doses, compared with -0.45% with placebo. Up to 40% of participants receiving retatrutide reached normoglycemia, defined in the report as HbA1c below 5.7%. The trial also recorded improvements in several cardiometabolic measures, including waist circumference, triglycerides, non-HDL cholesterol and high-sensitivity C-reactive protein.
The double-blind trial took place at 92 centers in eight countries. Participants received weekly injections of retatrutide or placebo alongside stable background glucose-lowering treatment. Eligible adults had a body mass index of at least 27 and type 2 diabetes. At the start of the study, average BMI was 38.2 and average HbA1c was 7.71%.
Weight Loss in Diabetes Care
The results address a treatment challenge identified by the investigators: people with type 2 diabetes tend to lose less weight than people without diabetes, including with weight-loss medicines and metabolic surgery. The 18.8% average loss in the 12-mg treatment-regimen group is therefore notable, while remaining a trial result for a drug that is not yet approved.
Comparisons with other medicines need care. The report cites prior trial averages of 13.2% with high-dose semaglutide and 15.7% with tirzepatide in people with diabetes. Those are results from separate studies, not a direct comparison with retatrutide. TRIUMPH-2 had no active-comparator arm, so it cannot establish which medicine works best when tested under the same conditions.
Weight and blood sugar outcomes may be relevant to people managing both obesity and diabetes, but the trial results do not establish long-term benefits or risks. Researchers also did not collect body-composition data to show how much weight loss came from fat versus lean mass. That leaves an important question about the nature of the weight change unanswered.
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How Retatrutide Works
Retatrutide is described in the report as a triple agonist that acts on the GIP, GLP-1 and glucagon hormone pathways. Frias said engaging those pathways may account for the weight loss observed. That explanation is the investigator’s interpretation of the results; the trial compared doses with placebo, not the drug’s individual pathways against one another.
Earlier trial results had reported greater weight loss with retatrutide among people without diabetes. Frias said the weight-loss level in TRIUMPH-2 had previously been seen with anti-obesity drugs in patients without diabetes. The report also notes that another investigational treatment, eloralintide combined with tirzepatide, was associated with 23.3% weight loss in a type 2 diabetes population in data presented at the same EASD meeting. These findings do not amount to a head-to-head comparison.
Retatrutide has attracted attention before approval, and the report says that interest has contributed to a gray market for the unapproved drug. Trial findings do not establish the safety, quality or effectiveness of products obtained outside authorized medical channels.
“We know that people with type 2 diabetes lose less weight than people without diabetes.”
— Juan P. Frias, MD, of the Los Angeles Institute for Metabolic Research, presenting the TRIUMPH-2 findings
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Safety and Long-Term Questions
The trial provides results through 80 weeks; it does not resolve how durable the weight loss may be or what longer-term effects treatment could have. It also did not include an active comparator, and the absence of body-composition data means researchers cannot report the proportions of lost weight that were lean mass and fat mass.
Gastrointestinal events—mainly nausea, diarrhea and constipation—were the most frequent adverse events. Treatment discontinuation due to gastrointestinal symptoms was reported in 0% to 2% of retatrutide groups, compared with 1% for placebo. Overall, 3% to 11% of participants in the retatrutide groups stopped treatment because of adverse events, compared with 5% on placebo. Hypotension and dysesthesia were more frequent in retatrutide groups, according to the report.
Seven participants died during the trial. The report says the deaths were deemed unrelated to the study interventions. The supplied results do not provide further detail on individual causes of death. The findings are clinical-trial evidence, not a determination that every potential risk has been identified.
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FDA Submission Planned for 2027
Eli Lilly, the developer, said it plans to submit the data to the U.S. Food and Drug Administration in early 2027. That is a planned regulatory step, not an approval date. The source material does not specify when an FDA decision might follow or whether additional studies or information will be required.
Until regulators review the evidence and make a decision, retatrutide remains investigational. Further reporting may clarify the full trial results, longer-term safety data and how the treatment compares with other options when studied directly. The current report establishes the trial’s weight and blood sugar findings, but not whether the drug will become available for routine care.
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Key Questions
How much weight did participants lose on retatrutide?
At week 80, average weight loss in the treatment-regimen analysis ranged from 11.9% with 4 mg to 18.8% with 12 mg. The placebo group lost an average of 5.1%. A separate efficacy analysis reported 20.8% loss with 12 mg and uses different assumptions.
Did retatrutide improve blood sugar in the trial?
Yes. Mean HbA1c fell by 1.38% to 1.50% across retatrutide doses, compared with 0.45% with placebo. Up to 40% of participants receiving retatrutide reached the study’s definition of normoglycemia: HbA1c below 5.7%.
Is retatrutide approved for use?
No approval is reported in the source material. Retatrutide remains investigational, and Eli Lilly said it plans to submit trial data to the FDA in early 2027.
What side effects were reported?
The most frequent adverse events were gastrointestinal, including nausea, diarrhea and constipation. Hypotension and dysesthesia were also reported more often in retatrutide groups. The trial report gives group-level findings and does not establish every possible risk.
Was retatrutide tested directly against other weight-loss drugs?
No. TRIUMPH-2 compared retatrutide doses with placebo and had no active-comparator arm. Results from separate studies of semaglutide or tirzepatide cannot establish which treatment performs better head to head.
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