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Studies
Srv5.5
Survodutide Research
Too few graded studies
33 peer-reviewed studies
What the evidence says
Too few graded studies
Survodutide doesn't have enough studies with structured effect-size data yet to pool a verdict. Browse the studies below for individual findings.
Most evidence is from high-quality meta-analyses and randomised trials published 2023–2026 with a typical study size of 216 participants.
Based on 33 studies · 5 meta-analyses · 12 RCTs · 982 total participants
Confidence
High confidence
By outcome
Weight managementPhase-2 4.8 mg dose produced ~-14.9% mean weight loss at 46 weeks; phase-3 SYNCHRONIZE-1 confirmed ~12-13% at 76 weeks · Progressive over 24-76 weeks
Too few graded studies26 studies
Glucose & glycemic controlDose-dependent HbA1c reductions in type 2 diabetes (pooled HbA1c -0.66% vs placebo) · By 16-46 weeks
Too few graded studies19 studies
Liver fat, MASH & fibrosisIn a 48-week phase-2 MASH/fibrosis trial, histologic MASH improvement without worsening fibrosis in up to 62% (4.8 mg) vs 14% placebo; phase-3 SYNCHRONIZE-MASLD met its endpoint · By 48 weeks
Too few graded studies13 studies
Safety profile
Mostly mechanism / observational8 studies
Active research area
33 studies in the last 5 years · Latest meta-analysis: 2026
20232026
1Meta-Analysis2026
Sun XY, Jiang HL, Ma YT, Xiong TQ, Leng XY, Zhao YF · J Transl Med (2026)
No plain-language summary recorded for this citation — open the paper to read its abstract.
In plain English: SGLT2 inhibitor and incretin-based agents improved fibrosis in MASH, with weight loss being a significant mediator.
Banerjee M, Pal R, Pal S. · Diabetes, obesity & metabolism (2026)
Meta-regression investigated the impact of percentage weight loss and baseline covariates on the proportion of individuals achieving histological end-points.
All active treatments, including Dapagliflozin 10 mg, Survodutide (2.4 mg/wk, 4.8-6 mg/wk), Tirzepatide (5 mg/wk, 10-15 mg/wk), and Semaglutide (0.7-1.4 mg/wk, 2.4 or 2.8 mg/wk), improved fibrosis versus placebo (I 2 = 0%).
For MASH resolution, dose-dependent effects led to significant heterogeneity (I 2 = 73%), with lower-dose Semaglutide demonstrating no benefits and Dapagliflozin showing benefits in the F2-F3 subgroup only on sensitivity analysis.
In plain English: 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
In plain English: 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 plain English: In people with a BMI ≥27 kg/m2, survodutide was associated with clinically meaningful reductions in bodyweight and waist circumference when compared with placebo, in prespecified subgroups based on sex and baseline BMI, and was tolerated at all doses tested.
le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hussain SA, Hennige AM. · Diabetes, obesity & metabolism (2025)
Participants with a lower baseline BMI had greater proportional reductions in bodyweight than those with a higher baseline BMI; the trend was reversed for reductions in waist circumference.
Rates of adverse events (AEs) were comparable between subgroups for sex and baseline BMI.
Nausea was the most frequently reported gastrointestinal AE in all subgroups.
In plain English: Balancing pharmacologic innovation with sustainable, equitable implementation remains the defining challenge ahead.
Lempesis IG, Dalamaga M. · Metabolism open (2026)
The amylin pathway has re-emerged through long-acting analogs (cagrilintide, eloralintide) and unimolecular co-agonists (amycretin), achieving weight reductions up to 24% via distinct neuroendocrine circuits.
Collectively, these advances signal a shift from appetite-centric weight loss toward integrated metabolic, neuroendocrine, and body-composition-focused disease modification.
The next epoch of obesity pharmacotherapy will be defined by multi-receptor strategic combinations, targeted approaches to preserve lean mass, and personalized treatment algorithms.
In plain English: Ongoing studies include but are not limited to survodutide, a glucagon/GLP-1 receptor dual agonist targeting metabolic drivers, efruxifermin, an FGF21 analog, and a conditionally approved drug resmetirom, which is a selective thyroid hormone receptor β agonist.
Patil R, Dunn W, Noureddin M, Alkhouri N. · Drugs (2026)
Future trial sample size hinges on the annual event rate and expected effect size.
From prior studies, event rates are ~ 3-20% higher with risk features.
Progression to large gastroesophageal varices is now an accepted endpoint and will typically add a 3-5% yearly event rate to the baseline MALO event rate.
In plain English: SYNCHRONIZE-1 will determine the efficacy, safety, and tolerability of survodutide, a glucagon receptor/GLP-1 receptor dual agonist, for weight loss in a representative cohort of people with obesity without T2D.
le Roux CW, Wharton S, Bozkurt B, Platz E, Bleckert G, Ajaz Hussain S, Brueckmann M, Startseva E, Kloer IM, Kaplan LM. · Diabetes, obesity & metabolism (2026)
The primary endpoints are percent body weight change and achievement of body weight reduction ≥5% from baseline to Week 76.
Most participants (59.4%) were female; 47.3% were from North America, 21.0% from Europe, and 20.0% from East Asia.
Obesity complications included hypertension (40.0%), dyslipidaemia (33.7%), and prediabetes (30.2%).
In plain English: This study provides updated rank-order efficacy of MASH pharmacological therapies for fibrosis regression and MASH resolution.
Souza M, Al-Sharif L, Antunes VLJ, Huang DQ, Loomba R. · Hepatology (Baltimore, Md.) (2025)
Pegozafermin, survodutide, tirzepatide, efruxifermin, liraglutide, vitamin E + pioglitazone, resmetirom, semaglutide, pioglitazone, denifanstat, semaglutide, and lanifibranor were significantly better than placebo in achieving MASH resolution without worsening fibrosis.
Conclusions This study provides updated rank-order efficacy of MASH pharmacological therapies for fibrosis regression and MASH resolution.
These data are helpful to inform practice and clinical trial design.
In plain English: In adults with obesity and type 2 diabetes, survodutide at a weekly dose of 3.6 mg or 6.0 mg resulted in significantly greater weight reduction than placebo. (Funded by Boehringer Ingelheim; SYNCHRONIZE-2 ClinicalTrials.gov number, NCT06066528.).
Wharton S et al. · The New England journal of medicine (2026)
Among 752 participants (250 in the 3.6-mg survodutide group, 251 in the 6.0-mg survodutide group, and 251 in the placebo group), the mean age at baseline was 55.7 years, and the mean BMI was 36.5; 49.3% were men.
The mean change in the glycated hemoglobin level (from a baseline level of 7.4%) was -0.9 percentage points in the 3.6-mg group, -0.8 percentage points in the 6.0-mg group, and -0.2 percentage points in the placebo group.
The most common adverse events were gastrointestinal (generally mild to moderate and transient), which occurred in 182 participants (72.8%) in the 3.6-mg group, 195 (77.7%) in the 6.0-mg group, and 97 (38.6%) in the placebo group.
In plain English: It also describes the key improvements in health status and the side effects experienced by people who took survodutide in clinical trials.
Almandoz JP, Miras AD, Seufert J, Paul E. · Therapeutic advances in gastroenterology (2026)
However, interventions such as medication and bariatric surgery are also effective treatments for metabolic dysfunction for those living with these diseases.
Such therapies can help people reach their health goals.
This review provides an overview of how survodutide works to help treat obesity and MASH.
In plain English: Future strategies rely on integrated, patient-centered approaches and personalized therapy to curb renal disease and its related complications.
Martínez-Castelao A, Górriz JL, Fernández-Fernández B, Soler MJ, Navarro-González JF. · Journal of clinical medicine (2025)
In our review, we summarize many of the principal trials that have generated evidence in this regard.
These new agents aim to slow disease progression further and reduce cardiovascular risk.
Future strategies rely on integrated, patient-centered approaches and personalized therapy to curb renal disease and its related complications.
In plain English: These trials are designed to provide robust evaluation of the efficacy, safety, and tolerability of survodutide for the treatment of obesity in the presence or absence of T2D.
Wharton S, le Roux CW, Kosiborod MN, Platz E, Brueckmann M, Jastreboff AM, Ajaz Hussain S, Pedersen SD, Borowska L, Unseld A, Kloer IM, Kaplan LM, SYNCHRONIZE‐1 and ‐2 trial committees and investigators. · Obesity (Silver Spring, Md.) (2025)
The primary endpoints are percentage change in body weight and proportion of participants achieving ≥5% body weight reduction from baseline to week 76.
Secondary endpoints include change in systolic blood pressure and measures of glycemia.
A SYNCHRONIZE-1 substudy is evaluating changes in body composition and liver fat content using magnetic resonance imaging.
In plain English: The optimal dose for clinical use ranges from 2.4 to 4.8 mg/week.
Dutta D, Kamrul-Hasan ABM, Joshi A, Dhall A, Nagendra L, Sharma M. · Indian journal of endocrinology and metabolism (2025)
Co-primary outcomes were the percent changes in body weight and HbA1c.
Survodutide at 2.4 mg [MD (mean difference) -7.79% (95% confidence interval [CI]: -11.54, -4.07); I 2 = 98%; P < 0.01] and 3.6 mg [MD - 9.08% (95% CI: -11.63, -6.54); I 2 = 96%; P < 0.001] was associated with significantly greater percent reductions in body weight compared to placebo.
The corresponding absolute body-weight reduction with survodutide 2.4 mg and 3.6 mg was - 9.14 kg (95% CI: -13.76, -4.53) and - 10.23 kg (95% CI: -15.43, -5.04), respectively.