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Srv5.5
Survodutide Research
Mostly mechanism / observationalLimited safety
9 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Survodutide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2024–2026 with a typical study size of 387 participants.
Based on 9 studies · 1 meta-analysis · 5 RCTs · 3,347 total participants
Confidence
High
By outcome
Weight management
Mostly mechanism / observational7 studies
Safety profile
Mostly mechanism / observational6 studies
Liver fat, MASH & fibrosis
Mostly mechanism / observational5 studies
Glucose & glycemic control
Mostly mechanism / observational5 studies
Active research area
9 studies in the last 5 years · Latest meta-analysis: 2025
1RCTn=725 · large study2026
At week 76, the mean change in body weight from baseline according to the treatment-regimen estimand was -12.2%... in the 3.6-mg group, -13.0%... in the 6.0-mg group, and -5.4%... in the placebo group; 72.6%, 71.9% and 46.3% of the participants, respectively, had weight reduction of at least 5% (P<0.001 for all comparisons with placebo).
le Roux CW, Wharton S, Startseva E, Kloer IM, Hussain SA, Unseld A, Bozkurt B, Ard JD, Bays HE, Bogdański P, Ekinci EI, Jastreboff AM, Ji L, Ogawa W, Pedersen SD, Pietiläinen KH, Sattar N, Seufert J, Stenlöf K, van Beek AP, Vangoitsenhoven R, Brueckmann M, Younes R, Kaplan LM; SYNCHRONIZE-1 Investigators. · N Engl J Med (2026)
Phase-3 double-blind RCT (n=725) of once-weekly subcutaneous survodutide 3.6/6.0 mg vs placebo over 76 weeks in adults with obesity WITHOUT diabetes — the first reported phase-3 survodutide efficacy trial
Mean weight loss -13.0% (6.0 mg) and -12.2% (3.6 mg) vs -5.4% placebo (treatment-regimen estimand); both co-primary endpoints met
Phase-3 weight loss (~12-13%) came in below the ~14.9% top-dose phase-2 planned-treatment figure, reflecting the more conservative treatment-regimen estimand and high placebo response
In total, 84.2% of survodutide-treated patients versus 24.3% of placebo-treated patients had ≥30% reduction in LFC using the efficacy estimand (P < 0.0001; treatment regimen estimand: 68.5% versus 28.6%, respectively; P < 0.0001). Mean percentage change in body weight was -12.2% with survodutide and -1.0% with placebo using the efficacy estimand.
Kaplan LM, Startseva E, le Roux CW, Wharton S, Bozkurt B, Mazo DF, von Schlippenbach J, González Maldonado S, Ajaz Hussain S, Neff GW, Gonzalez Rojas Y, Smith C, Younes R, Sanyal AJ; SYNCHRONIZE-MASLD Investigators. · Nat Med (2026)
Phase-3 double-blind RCT (n=216, randomized 2:1) of once-weekly subcutaneous survodutide 6.0 mg vs placebo over 48 weeks in adults with obesity and at-risk MASLD (MRI-PDFF/biopsy-defined)
Both co-primary endpoints met: ≥30% liver-fat (MRI-PDFF) reduction in 84.2% vs 24.3% placebo (efficacy estimand), and weight -12.2% vs -1.0% placebo
Extends the phase-2 MASH biopsy signal to a phase-3 imaging-based liver-fat endpoint
Improvement in MASH with no worsening of fibrosis occurred in 47% of the participants in the survodutide 2.4-mg group, 62% of those in the 4.8-mg group, and 43% of those in the 6.0-mg group, as compared with 14% of those in the placebo group.
Sanyal AJ, Bedossa P, Fraessdorf M, Neff GW, Lawitz E, Bugianesi E, Anstee QM, Hussain SA, Newsome PN, Ratziu V, Hosseini-Tabatabaei A, Schattenberg JM, Noureddin M, Alkhouri N, Younes R. · N Engl J Med (2024)
48-week phase-2, double-blind, randomized, placebo-controlled trial in 293 adults with biopsy-confirmed MASH and fibrosis stage F1-F3, once-weekly subcutaneous survodutide 2.4/4.8/6.0 mg vs placebo with a 24-week rapid-escalation then 24-week maintenance design
Primary endpoint met: histologic MASH improvement without worsening fibrosis in up to 62% (4.8 mg) vs 14% placebo
≥30% liver-fat reduction in 57-67% of treated groups vs 14% placebo; fibrosis improvement by ≥1 stage in 34-36% vs 22% placebo
Mean (95% CI) changes in bodyweight from baseline to week 46 were -6.2% (0.6 mg); -12.5% (2.4 mg); -13.2% (3.6 mg); -14.9% (4.8 mg); -2.8% (placebo). All tested survodutide doses were tolerated, and dose-dependently reduced bodyweight.
le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. · Lancet Diabetes Endocrinol (2024)
Phase-2, double-blind, randomized, placebo-controlled dose-finding trial in 387 adults with obesity (BMI ≥27) across 43 centres in 12 countries, once-weekly subcutaneous survodutide 0.6-4.8 mg vs placebo for 46 weeks
Dose-dependent weight loss reaching -14.9% at 4.8 mg (planned-treatment) vs -2.8% placebo at week 46
Adverse events in 91% of survodutide vs 75% placebo, primarily gastrointestinal (75% vs 42%); high discontinuation reduced the completer population
Survodutide reduced HbA1c levels and bodyweight after 16 weeks of treatment in participants with type 2 diabetes.
Blüher M, Rosenstock J, Hoefler J, Manuel R, Hennige AM. · Diabetologia (2024)
Phase-2, multicentre, double-blind, randomized, placebo-controlled dose-response trial in 413 adults with type 2 diabetes, once-weekly subcutaneous survodutide across six dose groups vs placebo, with an open-label semaglutide reference arm
Dose-dependent HbA1c reductions with survodutide vs placebo
Gastrointestinal adverse events were the most common, consistent with the incretin class
Survodutide significantly reduced HbA1c (WMD: -0.66%), body weight (WMD: -6.7 kg) and waist circumference (WMD: -7.09 cm)... however, it is crucial to highlight the significant increase in gastrointestinal AEs and the associated risk of treatment discontinuation.
Xiao YJ, Yu S, Zhang YL, Chen J, Liu YQ, Liu XL, Sun CF, Deng CL. · Diabetes Obes Metab (2025)
Systematic review and meta-analysis of 6 RCTs (n=1272) of survodutide vs placebo on glycemic control and weight
Pooled HbA1c -0.66%, fasting glucagon -7 pmol/L, bodyweight -6.7 kg and waist circumference -7.09 cm vs placebo, with modest improvements in BMI, lipids and blood pressure
Greater effects at total weekly doses >2.4 mg and durations >16 weeks
Survodutide's dual agonism of the GCGR and GLP-1 R may surpass the efficacy of selective GLP-1 R agonists, demonstrating significant potential in resolving MASH and promoting fibrosis regression.
Kaya E, Yilmaz Y, Alkhouri N. · Expert Opin Investig Drugs (2024)
Review of survodutide's pharmacology, phase-1/phase-2 efficacy and safety in obesity and MASH
Frames the dual GCGR/GLP-1R mechanism as potentially superior to GLP-1 mono-agonism for MASH and fibrosis regression — an area where GLP-1 agonists alone have unproven fibrosis benefit
Notes generally manageable, primarily gastrointestinal adverse effects
Survodutide is generally tolerable in people with compensated or decompensated cirrhosis, does not require pharmacokinetic-related dose adjustment, and may improve liver-related non-invasive tests, supporting its investigation for MASH-related cirrhosis.
Lawitz EJ, Fraessdorf M, Neff GW, Schattenberg JM, Noureddin M, Alkhouri N, Schmid B, Andrews CP, Takács I, Hussain SA, Fenske WK, Gane EJ, Hosseini-Tabatabaei A, Sanyal AJ, Mazo DF, Younes R. · J Hepatol (2024)
Multinational, non-randomized, open-label phase-1 trial of subcutaneous survodutide in people with Child-Pugh A/B/C cirrhosis vs matched healthy/overweight controls (single-dose cohorts n=41)
Pharmacokinetics did not require dose adjustment for cirrhosis severity; survodutide was generally tolerable including in decompensated cirrhosis
Associated reductions in liver-fat content, markers of liver fibrosis and bodyweight
Phase 2 trials have demonstrated weight loss up to 18.7% and HbA1c reductions up to -1.71%, outperforming semaglutide for weight outcomes while maintaining comparable glycemic efficacy... Adverse events, primarily gastrointestinal intolerance and modest heart rate increases, remain important limitations.
Arun AJ, Darji B, Baig M, Frishman WH, Aronow WS. · Cardiol Rev (2025)
Cardiometabolic-focused review summarising survodutide's broad metabolic effects across obesity, type 2 diabetes and MASH
Cites phase-2 weight loss up to 18.7% and HbA1c reductions up to -1.71%, with hepatic fat reduction and anti-inflammatory signals
Flags modest heart-rate increases and GI intolerance driving higher discontinuation than comparators as key limitations