Survodutide for the treatment of obesity disease in Japanese participants: rationale, design and baseline characteristics of the phase 3 SYNCHRONIZE-JP trial$dclinical study design
Aims There is an unmet need for effective pharmacotherapy for obesity disease management in Japan. Survodutide is a novel glucagon receptor/glucagon-like peptide-1 receptor (GLP-1R) dual agonist with the potential to induce greater weight reductions than GLP-1R mono-agonists. We report the design an...
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| Autores principales: | , , , , , , , , , |
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| Formato: | Article (Journal) |
| Lenguaje: | inglés |
| Publicado: |
2026
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| In: |
Diabetes, obesity and metabolism
Year: 2026, Pages: 1-12 |
| ISSN: | 1463-1326 |
| DOI: | 10.1111/dom.70862 |
| Acceso en línea: | Verlag, kostenfrei, Volltext: https://doi.org/10.1111/dom.70862 Verlag, kostenfrei, Volltext: https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.70862 
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| Notas de Autor: | Koutaro Yokote, Toshimasa Yamauchi, Yasushi Fukushima, Yoji Takatsuka, Marie Kato, Shijia Yan, Takayoshi Inoue, Luiza Borowska, Martina Brueckmann, Wataru Ogawa, on behalf of the SYNCHRONIZE-JP Trial Investigators |
| Sumario: | Aims There is an unmet need for effective pharmacotherapy for obesity disease management in Japan. Survodutide is a novel glucagon receptor/glucagon-like peptide-1 receptor (GLP-1R) dual agonist with the potential to induce greater weight reductions than GLP-1R mono-agonists. We report the design and baseline participant characteristics of the SYNCHRONIZE-JP trial evaluating survodutide in Japanese adults with obesity disease (ClinicalTrials.gov: NCT06176365). Materials and Methods SYNCHRONIZE-JP is a 76-week, randomised, double-blind, parallel-group, multi-centre, phase 3 clinical trial. Eligible participants were aged ≥ 18 years, with BMI ≥ 35 kg/m2 with ≥ 1 obesity complication or BMI ≥ 27 kg/m2 with ≥ 2 obesity complications, ≥ 1 self-reported unsuccessful dietary effort to lose body weight and ≥ 1 obesity complication required to be type 2 diabetes (T2D; capped at 30% enrolment), hypertension or dyslipidaemia. Participants were randomised 1:1:1 to receive once-weekly survodutide 3.6 or 6.0 mg, or placebo, accompanied by a reduced-calorie diet and increased physical activity. The primary endpoints are percentage change in body weight and achievement of body weight reduction ≥ 5% from baseline to Week 76. A subset of participants will be assessed for additional endpoints of liver fat content and body composition. Results Of 274 enrolled participants, 24.1% had T2D. The mean age was 53.1 years; 47.8% were female, and mean BMI was 33.2 kg/m2. The most frequent complications were dyslipidaemia (81.4%), hypertension (72.6%), hyperuricaemia (30.3%) and metabolic dysfunction-associated steatotic liver disease (26.6%). Conclusions The results of SYNCHRONIZE-JP will provide Japan-specific efficacy, safety and tolerability data for survodutide and inform its potential role in the management of obesity disease. |
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| Notas: | Erstmals veröffentlicht: 31. Mai 2026 Gesehen am 22.06.2026 |
| Descripción Física: | Online Resource |
| ISSN: | 1463-1326 |
| DOI: | 10.1111/dom.70862 |