TL;DR
Get health and wellness essentials delivered free — and shop member deals
- Fast, free delivery on millions of items
- Access to Prime Big Deal Days deals on October 6–7
- Prime Video, Amazon Music and more included
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 at week 80, depending on dose, compared with 5.1% on placebo. The investigational drug also improved blood sugar measures; it is not approved, and Eli Lilly says it plans to submit data to the FDA in early 2027.
A phase III trial found that adults with obesity and type 2 diabetes who received investigational retatrutide lost an average of 11.9% to 18.8% of their body weight after 80 weeks, compared with 5.1% for placebo. The TRIUMPH-2 results also showed improved blood sugar measures, adding evidence for a drug that is not yet approved for use.
The trial included 1,152 participants assigned to once-weekly injections of retatrutide at 4 mg, 9 mg or 12 mg, or to placebo. In the treatment regimen estimand, which reflects outcomes in the trial treatment setting, average weight loss at week 80 was 11.9% with 4 mg, 16.8% with 9 mg and 18.8% with 12 mg. The placebo group lost 5.1% on average.
Researchers also reported results using an efficacy estimand that assumes participants took the study medication as intended and excludes the effects of certain events that can affect treatment assessment. Under that approach, the highest-dose group lost 20.8% of body weight. Juan P. Frias, the trial presenter and a researcher at the Los Angeles Institute for Metabolic Research, said more than half of participants in that analysis lost over 15% of their body weight.
Retatrutide improved HbA1c, a measure of average blood glucose. Mean HbA1c reductions were 1.38 to 1.50 percentage points across the three doses, compared with 0.45 points 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 cardiometabolic measures, including waist circumference, triglycerides, non-HDL cholesterol and high-sensitivity C-reactive protein.
Weight Loss in Diabetes Care
People with type 2 diabetes have generally lost less weight in trials of weight-loss treatments than people without diabetes, Frias said. The TRIUMPH-2 results suggest retatrutide may achieve substantial weight reduction in this population while also improving HbA1c. That combination is relevant because participants had both obesity and diabetes, and were already receiving stable glucose-lowering treatment.
The trial authors described a need for more effective weight reduction options for people with obesity and type 2 diabetes. Still, these findings are trial results for an investigational drug, not proof that retatrutide is safe or suitable for every patient, and they do not establish how it compares directly with other treatments.
As an affiliate, we earn on qualifying purchases.
How TRIUMPH-2 Was Conducted
TRIUMPH-2 was a double-blind, placebo-controlled trial conducted at 92 medical and research centers in eight countries. Participants had a body mass index of at least 27, an HbA1c between 6.5% and 10.5%, and were on stable treatment with up to three oral glucose-lowering medicines. They also had a history of trying to lose weight through diet.
Retatrutide acts on three hormone receptors: GIP, GLP-1 and glucagon. Frias said engaging these pathways may help account for the weight loss observed. The current trial did not include an active comparison group. The report notes that prior trials of high-dose semaglutide and tirzepatide in people with diabetes found average weight losses of 13.2% and 15.7%, respectively, but differences across separate studies mean those figures are not a direct comparison with TRIUMPH-2.
“We know that people with type 2 diabetes lose less weight than people without diabetes.”
— Juan P. Frias, MD, trial presenter
As an affiliate, we earn on qualifying purchases.
Safety and Comparison Questions
The trial did not compare retatrutide directly with an approved weight-loss medicine, so it cannot establish whether it is more effective than alternatives. Researchers also did not collect body-composition data to determine how much of the weight lost was lean mass rather than fat.
Gastrointestinal events, mainly nausea, diarrhea and constipation, were the most frequent adverse events. Discontinuation because of gastrointestinal symptoms was reported in 0% to 2% of retatrutide groups and 1% of the placebo group. Overall, 3% to 11% of participants in retatrutide groups discontinued treatment because of adverse events, compared with 5% on placebo. Hypotension and dysesthesia occurred more often in the retatrutide groups. Seven participants died during the trial; investigators deemed the deaths unrelated to the study interventions.
The results do not settle how the drug’s benefits and risks will compare in broader use. Retatrutide remains investigational, and the supplied report does not provide an FDA decision or a final approval timeline.
diabetes management blood sugar monitor
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
FDA Submission Planned for 2027
Eli Lilly, the drug’s developer, said it plans to submit the trial data to the U.S. Food and Drug Administration in early 2027. That submission would be a next regulatory step, not an approval. Any decision will depend on the FDA’s review of the submitted evidence. Further information on the trial and the drug’s safety and effectiveness may emerge as regulatory materials and additional study results become available.
As an affiliate, we earn on qualifying purchases.
Key Questions
How much weight did participants lose?
At week 80, average loss in the treatment regimen analysis ranged from 11.9% with 4 mg to 18.8% with 12 mg. Participants given placebo lost 5.1% on average.
Did retatrutide improve blood sugar measures?
Yes. Mean HbA1c fell by 1.38 to 1.50 percentage points across the retatrutide doses, compared with 0.45 points with placebo. Up to 40% of participants receiving retatrutide reached the study’s normoglycemia threshold, HbA1c below 5.7%.
Is retatrutide approved?
No. Retatrutide is an investigational drug. Eli Lilly said it plans to submit data to the FDA in early 2027; that is not the same as regulatory approval.
What side effects were reported?
The most frequent adverse events were gastrointestinal, particularly nausea, diarrhea and constipation. Hypotension and dysesthesia occurred more often in retatrutide groups. The trial report says investigators judged the seven deaths during the study to be unrelated to the study interventions.
Source: rss
Halloween Picks
halloween
As an affiliate, we earn on qualifying purchases.
