Summary:
In adults with obesity without type 2 diabetes (n=725) enrolled in the phase 3 SYNCHRONIZE-1 trial across 14 countries, once-weekly survodutide (3.6 or 6.0 mg), a GLP-1/glucagon dual agonist is being evaluated for percent body weight change and ≥5% weight reduction over 76 weeks compared to placebo, with baseline showing mean BMI 37.9 kg/m², 59.4% female, and high comorbidity prevalence (hypertension 40%, dyslipidemia 34%, prediabetes 30%).
| PICO | Description |
|---|---|
| Population | Adults aged ≥18 years with BMI ≥30 or ≥27 kg/m² with ≥1 obesity complication, without type 2 diabetes (n=725 from 14 countries). Mean age 47.1 years, BMI 37.9 kg/m², waist 115.2 cm, 59.4% female. |
| Intervention | Once-weekly subcutaneous survodutide, up-titrated to 3.6 mg or 6.0 mg, for 76 weeks (1:1:1 randomization to survodutide 3.6 mg, 6.0 mg, or placebo). |
| Comparison | Placebo subcutaneous injection once weekly for 76 weeks. |
| Outcome | Primary endpoints: Percent body weight change and achievement of ≥5% weight reduction from baseline to Week 76. This publication reports baseline characteristics; efficacy results pending trial completion. |
Clinical Context
The landscape of obesity pharmacotherapy is rapidly evolving, with GLP-1 receptor agonists demonstrating unprecedented efficacy. The addition of glucagon receptor agonism to GLP-1 activity represents the next frontier, potentially enhancing weight loss through increased energy expenditure and hepatic lipid oxidation beyond GLP-1 effects alone. Survodutide is one of several GLP-1/glucagon dual agonists in development.
Survodutide showed promising results in phase 2 trials, achieving weight loss comparable to or exceeding available GLP-1 agonists. SYNCHRONIZE-1 is one of two phase 3 trials investigating survodutide for obesity management—this trial focuses on adults without type 2 diabetes, while a companion trial enrolls patients with diabetes.
This publication provides detailed baseline characteristics of the enrolled population, establishing the foundation for interpreting future efficacy and safety results. Understanding the study population is essential for assessing generalizability and comparing across trials.
Clinical Pearls
1. Representative Obesity Population: The baseline BMI of 37.9 kg/m² represents Class II obesity, similar to populations in other major obesity trials (STEP, SURMOUNT). The inclusion of patients with BMI ≥27 with complications broadens applicability to overweight individuals with comorbidities.
2. High Comorbidity Burden: 40% had hypertension, 33.7% had dyslipidemia, and 30.2% had prediabetes. These comorbidities reflect real-world obesity populations and will enable assessment of cardiometabolic benefits beyond weight loss.
3. Global Representation: Enrollment across 14 countries (47.3% North America, 21% Europe, 20% East Asia) ensures diverse population representation. The East Asian cohort is particularly valuable given different obesity phenotypes and metabolic responses in this population.
4. Prediabetes Subgroup: With 30.2% having prediabetes, the trial can assess diabetes prevention effects. Given GLP-1/glucagon agonists’ metabolic effects, conversion to diabetes may be significantly reduced.
Practical Application
While efficacy results are pending, the baseline data inform clinical practice planning. Survodutide targets a population similar to current tirzepatide and semaglutide users, suggesting potential future substitutability or alternative options for non-responders.
The 76-week treatment duration will provide long-term efficacy and safety data essential for chronic obesity management. The two-dose design (3.6 mg and 6.0 mg) will inform optimal dosing strategies.
For patients asking about emerging obesity treatments, survodutide can be mentioned as a promising GLP-1/glucagon dual agonist in late-stage development, with results expected after trial completion.
Broader Evidence Context
Survodutide joins a competitive field of dual agonists including pemvidutide (GLP-1/glucagon) and tirzepatide (GIP/GLP-1). The glucagon component differentiates survodutide from tirzepatide and may offer advantages for hepatic steatosis and energy expenditure. Phase 2 data showed up to 18-19% weight loss, competitive with tirzepatide.
Boehringer Ingelheim’s development of survodutide adds a major pharmaceutical player to the obesity therapeutics space, potentially increasing competition and access.
Study Limitations
This publication reports only baseline characteristics; efficacy and safety results are pending. Exclusion of type 2 diabetes limits applicability to the common obesity-diabetes overlap population (addressed in companion trial). 76-week duration, while substantial, may not capture very long-term outcomes. Drop-out rates and adherence to dose titration will affect intent-to-treat results.
Bottom Line
SYNCHRONIZE-1 has enrolled a representative global population of 725 adults with obesity and high comorbidity burden to evaluate survodutide, a novel GLP-1/glucagon dual agonist, over 76 weeks, with efficacy results expected to inform the future role of this drug class in obesity management.
Source: le Roux CW, et al. “Survodutide for treatment of obesity: Baseline characteristics of participants in a randomized, double-blind, placebo-controlled, phase 3 trial (SYNCHRONIZE™-1).” Diabetes Obes Metab. 2026;28(1):337-346. Read article
