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In the phase III SYNCHRONIZE-2 trial, adults with obesity and type 2 diabetes taking survodutide lost more weight and had greater HbA1c reductions than those taking placebo over 76 weeks. Gastrointestinal side effects were common, and treatment-related discontinuation was higher with survodutide. The investigational drug’s benefits and tolerability will need further study.
The investigational drug survodutide helped adults with obesity and type 2 diabetes lose more weight than placebo over 76 weeks, but gastrointestinal side effects led substantially more participants to stop treatment, according to phase III SYNCHRONIZE-2 results presented at the European Association for the Study of Diabetes meeting. The findings point to a trade-off between measurable weight and blood-sugar improvements and a tolerability problem that may affect whether patients can stay on the medicine.
Participants assigned to once-weekly injections of 3.6 mg or 6 mg survodutide lost an average of 8.2% and 9.8% of their body weight by week 76, respectively. The placebo group lost an average of 3.9%. At least 5% weight loss occurred in 57.6% of the 3.6-mg group, 64.5% of the 6-mg group and 35.1% of the placebo group; the trial report gave P<0.001 for each comparison with placebo.
Average HbA1c, a measure of blood glucose over time, fell by 0.9 percentage points with 3.6 mg and 0.8 points with 6 mg, compared with 0.2 points on placebo. Mean HbA1c at the start was 7.4%. Sean Wharton of Wharton Medical Clinic Weight and Diabetes Management in Hamilton, Ontario, reported the findings at the meeting. He said survodutide was also associated with changes in systolic blood pressure, waist circumference and lipid measures.
However, gastrointestinal adverse events affected 73% to 78% of participants taking survodutide, compared with 38.6% on placebo. Most events were described as mild to moderate and transient, but gastrointestinal effects prompted 18% of participants in each survodutide group to discontinue the trial regimen, against 1.2% in the placebo group. Adverse events of any kind led to treatment discontinuation in 26% of each survodutide group and 9% of the placebo group.
Benefits Came With Dropout Concerns
The results matter because weight loss and improved blood sugar may benefit people managing both obesity and type 2 diabetes, while side effects can limit how many patients remain on treatment. In this trial, the weight and HbA1c measures favored survodutide, but the comparatively high rate of stopping treatment is a substantial limitation for evaluating its practical value.
Andreas Birkenfeld of University Hospital Tübingen said the trial showed no additional safety signal beyond what was already known about the drug, while highlighting the discontinuation rate from gastrointestinal events. MedpageToday reported that he contrasted the rate with figures of up to 5% for high-dose semaglutide and up to 2% for investigational retatrutide. These are comparisons reported by Birkenfeld, not results from a head-to-head trial, so they do not establish which medicine is more effective or better tolerated across comparable patients.
The weight reduction in the 6-mg group was described by the researchers as a magnitude associated with cardiovascular benefits and fewer metabolic and mechanical complications, as well as improved quality of life. That is an interpretation of the observed weight loss, not evidence that this trial demonstrated fewer cardiovascular events or improved quality of life.
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What SYNCHRONIZE-2 Tested
The multinational, double-blind study enrolled 752 adults: 250 received 3.6 mg survodutide, 251 received 6 mg and 251 received placebo. All had type 2 diabetes and a body mass index of at least 27. Participants’ mean age was 55.7, mean BMI was 36.5, and 49.3% were men. Treatment was given by weekly injection.
The findings were presented at the EASD annual meeting in Milan and published simultaneously in the New England Journal of Medicine, according to the source report. The study authors acknowledged that the weight loss was below the maximum 13% reported in SYNCHRONIZE-1, an earlier trial that excluded people with diabetes. Results from separate studies should not be read as direct comparisons because the enrolled populations and trial conditions differ.
SYNCHRONIZE-2 excluded people taking insulin. Most participants had relatively well-controlled blood sugar at baseline while using oral glucose-lowering medicines. Those features limit how confidently the findings can be applied to the broader population of people with type 2 diabetes, particularly those using insulin or with less-controlled glucose levels.
““It’s reassuring we see no additional safety signal beyond what we already know.””
— Andreas Birkenfeld, MD, PhD, of University Hospital Tübingen
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Questions on Tolerability and Reach
The trial does not establish whether a different dose-escalation schedule will reduce gastrointestinal symptoms or treatment discontinuation. Birkenfeld suggested the 24-week, six-step escalation used for the 6-mg dose could help explain the dropout rate, and said the schedule had been requested by the FDA. That proposed explanation is not proven by these results.
It is also unclear how well the findings apply to people taking insulin or those whose diabetes is less controlled, because they were not well represented or were excluded. The results do not show whether survodutide prevents heart attacks or other cardiovascular events; the source report said a cardiovascular outcomes trial is underway, with data expected later this year. The supplied report does not specify the date of that expected release.
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Future Trials Will Test Dosing
Boehringer Ingelheim says future trials will use more flexible, patient-centered titration strategies intended to improve tolerability. Those studies will need to establish whether adjusting dose increases can reduce side effects and discontinuations while preserving the observed weight and HbA1c effects.
Data from a separate cardiovascular outcomes trial are expected later this year, according to the report. Until those results and further trial evidence are available, survodutide remains investigational, and the current findings should be understood within the limits of the participants and treatment schedule studied.
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Key Questions
How much weight did participants lose with survodutide?
By week 76, average weight loss was 8.2% with 3.6 mg and 9.8% with 6 mg. Participants receiving placebo lost an average of 3.9%.
Did survodutide improve blood sugar levels?
Average HbA1c fell by 0.9 percentage points with 3.6 mg and 0.8 points with 6 mg, compared with 0.2 points with placebo. The study’s average starting HbA1c was 7.4%.
What were the main side effects reported?
Gastrointestinal adverse events were reported by 73% to 78% of participants taking survodutide, versus 38.6% of those on placebo. The report said most were mild to moderate and transient, but gastrointestinal events led 18% in each treatment group to discontinue the trial regimen.
Can these results be applied to everyone with type 2 diabetes?
Not directly. The trial excluded people taking insulin, and most participants had relatively well-controlled blood sugar while using oral medicines. The findings may not represent people with less-controlled diabetes or those on insulin.
What evidence is expected next?
The developer says upcoming trials will test more flexible dose titration, and the source report says cardiovascular outcomes trial data are expected later this year. Neither the effect of the new dosing approach nor the cardiovascular results are established by SYNCHRONIZE-2.
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