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In the phase III TRIUMPH-2 trial, adults with obesity and type 2 diabetes who received retatrutide lost an average of 11.9% to 18.8% of their body weight at week 80, depending on dose, compared with 5.1% with placebo. The investigational drug also improved HbA1c, but the study had no active-drug comparator, and Eli Lilly says it plans to submit data to the FDA in early 2027.
Adults with obesity and type 2 diabetes who received investigational retatrutide in a phase III trial lost an average of 11.9% to 18.8% of their body weight after 80 weeks, compared with 5.1% among participants given placebo. The TRIUMPH-2 results, presented at the European Association for the Study of Diabetes annual meeting and published in The Lancet, also showed improved blood-sugar measures; retatrutide is not yet approved.
The double-blind trial randomized 1,152 participants to weekly injections of retatrutide at doses of 4, 9 or 12 milligrams, or placebo. In the treatment-regimen analysis, which reflects outcomes while accounting for events that may affect treatment, average body-weight reductions at week 80 were 11.9% with 4 mg, 16.8% with 9 mg and 18.8% with 12 mg. The placebo group lost an average of 5.1%.
The investigators also reported results using an efficacy estimand, which assumes participants took study medication as intended and excludes certain events that can affect interpretation. Under that analysis, the highest-dose group lost 20.8% of body weight. That figure is not the same measure as the 18.8% treatment-regimen result and should not be read as the average outcome under all trial circumstances.
Retatrutide was associated with reductions in HbA1c, a measure of average blood glucose. Mean changes from baseline were −1.38 percentage points with 4 mg, −1.50 with 9 mg and −1.45 with 12 mg, compared with −0.45 with placebo. Up to 40% of retatrutide-treated participants reached normoglycemia, defined in the report as HbA1c below 5.7%. The study also reported improvements in several other measured cardiometabolic outcomes, including waist circumference, triglycerides, non-HDL cholesterol and high-sensitivity C-reactive protein.
Weight Loss in Diabetes Treatment
The findings address a treatment gap for people who have both obesity and type 2 diabetes. Trial presenter Juan P. Frias said people with diabetes generally lose less weight than people without diabetes, regardless of whether weight loss comes from medication or metabolic surgery. The results suggest retatrutide could produce sizable weight reductions in this population, alongside lower HbA1c in the trial.
That comparison needs care: TRIUMPH-2 did not include an active comparator, so it cannot directly establish how retatrutide performs against another weight-loss medicine. The report cites prior trial averages of 13.2% weight loss with high-dose semaglutide and 15.7% with tirzepatide in people with diabetes, but those figures come from separate studies. Differences in trial design and participants mean they are not a head-to-head comparison.
The findings are also relevant to safety and treatment decisions, not only the amount of weight lost. Retatrutide remains investigational; the trial results do not establish approval, long-term outcomes or how benefits and risks compare with available medicines in direct testing.
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How TRIUMPH-2 Was Conducted
TRIUMPH-2 was a double-blind, placebo-controlled phase III trial conducted at 92 medical and research centers in eight countries. Participants had a body mass index of at least 27, type 2 diabetes with HbA1c between 6.5% and 10.5%, and stable background glucose-lowering treatment for at least 90 days before screening. They also had a history of trying diet-based weight loss.
At the start of the trial, the average BMI was 38.2, average HbA1c was 7.71%, median obesity duration was 21 years and median diabetes duration was 5.6 years. Participants received once-weekly injections for the study period. Frias said the highest-dose efficacy-estimand result exceeded 20% weight loss, with more than half of participants in that analysis losing over 15%.
The investigators noted that weight loss in TRIUMPH-2 remained below the 28.3% reported in TRIUMPH-1, which studied retatrutide in people without diabetes. The comparison is between different trial populations, rather than a direct test of the effect of diabetes on response. Retatrutide acts on GIP, GLP-1 and glucagon receptors, according to the report; Frias said engaging these pathways may help explain the observed weight loss.
“We know that people with type 2 diabetes lose less weight than people without diabetes. We see this irrespective of the weight-loss method, whether it’s pharmacotherapy or metabolic surgery.”
— Juan P. Frias, MD, Los Angeles Institute for Metabolic Research, as quoted in MedPage Today
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Safety and Comparison Questions
The report describes gastrointestinal effects—mainly nausea, diarrhea and constipation—as the most frequent adverse events. Discontinuation because of gastrointestinal symptoms was reported in 0% to 2% of retatrutide recipients, compared with 1% of placebo recipients. Across the dose groups, 3% to 11% stopped study treatment because of adverse events, compared with 5% in the placebo group. Hypotension and dysesthesia were reported more often in retatrutide arms.
Seven participants died during the trial; the report says investigators deemed all deaths unrelated to the study interventions. The supplied results do not provide enough detail to assess individual circumstances. The investigators also identified limitations: there was no active comparator, and the study did not measure body composition to determine the proportions of weight lost as fat and lean mass.
The results do not establish how retatrutide compares directly with other drugs, whether the observed changes persist beyond the 80-week trial, or how its longer-term benefits and risks balance. The findings are trial results, not evidence that the unapproved medicine is available for routine treatment.
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FDA Submission Planned for 2027
Eli Lilly said it plans to submit data to the U.S. Food and Drug Administration in early 2027. A planned submission is not an approval, and the supplied report does not specify a decision timeline or whether additional studies will be required. Until regulatory review is complete, retatrutide remains investigational.
Further reporting may clarify the FDA submission and any additional evidence on safety, durability of weight loss and body composition. For now, TRIUMPH-2 provides results from an 80-week placebo-controlled trial; it does not answer all questions about longer-term use or comparative effectiveness.
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Key Questions
How much weight did participants lose with 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 5.1% on average. In a separate efficacy estimand, which assumes participants took treatment as intended, the 12-mg group lost 20.8%.
Did retatrutide improve blood-sugar control?
Yes. Mean HbA1c changes from baseline ranged from −1.38 to −1.50 percentage points across the retatrutide doses, compared with −0.45 with placebo. The trial also reported that up to 40% of retatrutide-treated participants reached HbA1c below 5.7%.
Is retatrutide approved?
No. Retatrutide is investigational. Eli Lilly said it plans to submit data to the FDA in early 2027; that plan is not an approval or a guarantee of when a regulatory decision will be made.
What side effects were reported?
The most frequent adverse events were nausea, diarrhea and constipation. Hypotension and dysesthesia occurred more often in retatrutide groups, according to the report. The trial also recorded deaths that investigators judged unrelated to study interventions.
Was retatrutide compared directly with other weight-loss drugs?
No. TRIUMPH-2 compared retatrutide with placebo, not an active medicine. Weight-loss figures from other drugs cited in the report come from separate trials and cannot establish which treatment performs better head to head.
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