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Semaglutide – Forschung
Überwiegend Mechanismus / Beobachtung
36 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Semaglutide sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2016–2026 mit einer typischen Studiengröße von 1,210 Teilnehmenden.
Basierend auf 36 Studien · 14 Meta-Analysen · 15 RCTs · 130,288 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Weight managementErhebliche Gewichtsabnahme — durchschnittlich etwa 15 % Reduktion des Körpergewichts unter 2,4 mg über 68 Wochen bei Erwachsenen mit Adipositas (STEP 1); über die Hälfte verliert ≥15 % · Monate (Titration über 16-20 Wochen)
Überwiegend Mechanismus / Beobachtung24 Studien
Blood sugar & glycemic controlGroße, konsistente HbA1c-Senkungen über die Phase-3-Programme SUSTAIN/PIONEER hinweg; im direkten Vergleich Dulaglutid überlegen · Wochen bis Monate · Die Kombination aus glykämischer Kontrolle und deutlicher Gewichtsreduktion verbessert den metabolischen Gesamtstatus · Monate
Überwiegend Mechanismus / Beobachtung16 Studien
Safety & adverse effects
Überwiegend Mechanismus / Beobachtung15 Studien
Cardiovascular outcomes20-26 % relative Reduktion schwerwiegender kardiovaskulärer Ereignisse in eigens dafür konzipierten Endpunktstudien (SUSTAIN-6, SELECT) · Monate bis Jahre
Überwiegend Mechanismus / Beobachtung11 Studien
Aktives Forschungsgebiet
32 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2026
201620212026
1Meta-Analysen=906 · large study2026
In this systematic review and meta-analysis, GLP-1 RAs produced greater weight loss among women than men; however, their efficacy was consistent across other important subpopulations.
Alexander GC et al. · JAMA internal medicine (2026)
Of these, 48 RCTs could be individually characterized: they had a mean (SD) study population of 1181 (2513) participants; 51 trials were parallel (98.1%); 51 multicenter (98.1%); and 21 evaluated semaglutide (43.8%) and 9, dulaglutide (18.8%).
HTE was most commonly evaluated using baseline BMI (36 RCTs [75.0%]), HbA1c (24 [50.0%]), and age (21 [43.8%]), and less commonly, ethnicity (12 [25.0%]), race (11 [22.9%]), and sex (10 [20.8%]).
Among 6 trials (19 906 patients) analyzed by sex, weight loss was greater among women (10.9%; 95% CI, 7.0%-14.8%) than men (6.8%; 95% CI, 4.6%-9.0%).
A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; 95% confidence interval, 0.72 to 0.90; P<0.001).
Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornøe CW, Ryan DH; SELECT Trial Investigators. · N Engl J Med (2023)
Large cardiovascular-outcomes RCT: 17,604 patients with preexisting cardiovascular disease and overweight/obesity but WITHOUT diabetes
Subcutaneous semaglutide 2.4 mg/week reduced cardiovascular death, nonfatal MI, or nonfatal stroke by 20% (HR 0.80; 95% CI 0.72-0.90; P<0.001) over ~40 months
6.5% vs 8.0% event rate; established a cardiovascular benefit in a non-diabetic obese population
The mean change in body weight from baseline to week 68 was -14.9% in the semaglutide group as compared with -2.4% with placebo, for an estimated treatment difference of -12.4 percentage points.
Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. · N Engl J Med (2021)
Double-blind RCT in 1,961 adults with obesity/overweight WITHOUT diabetes, randomized 2:1 to subcutaneous semaglutide 2.4 mg/week or placebo plus lifestyle for 68 weeks
Mean body-weight change -14.9% (semaglutide) vs -2.4% (placebo); treatment difference -12.4 percentage points (95% CI -13.4 to -11.5; P<0.001)
Weight reduction ≥5% in 86.4% vs 31.5%; ≥10% in 69.1% vs 12.0%; ≥15% in 50.5% vs 4.9%
The primary outcome occurred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.58 to 0.95; P<0.001 for noninferiority).
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T; SUSTAIN-6 Investigators. · N Engl J Med (2016)
Pre-approval cardiovascular-safety RCT in 3,297 patients with type 2 diabetes at high cardiovascular risk, semaglutide (0.5/1.0 mg/week) vs placebo for 104 weeks
Translations For the Japanese and Mandarin translations of the abstract see Supplementary Materials section.
Yamauchi T, Becker NP, Hagemann CA, Huang KC, Kiyosue A, Lim S, Onishi Y, Kosuvaripalli A, Takano T, Ishigaki Y, REDEFINE 5 study group. · The lancet. Diabetes & endocrinology (2026)
The estimated mean change in bodyweight from baseline to week 68 was -18·4% (SE 0·7) in the cagrilintide-semaglutide group versus -11·9% (0·7) in the semaglutide group (estimated treatment difference [ETD] -6·5 percentage points [95% CI -8·4 to -4·6]; p<0·0001).
One death was reported in the semaglutide 2·4 mg group, which was not judged to be treatment related by the investigator.
Interpretation These findings support the efficacy and safety of cagrilintide-semaglutide for weight management in individuals from east Asia with overweight or obesity, with or without type 2 diabetes.
In this secondary analysis of the SOUL randomized clinical trial, among individuals with T2D, atherosclerotic CV disease, and/or chronic kidney disease, a reduction of HF events was observed with use of oral semaglutide compared with placebo in those with a history of HF, without increasing the risk of serious adverse events.
Pop-Busui R et al. · JAMA internal medicine (2026)
Overall, 9650 participants (median [IQR] age, 66.0 [61.0-72.0] years; 2790 [28.9%] female) were randomized, with a mean (SD) follow-up of 47.5 (10.9) months.
Of these participants, 2229 (23.1%) had HF history (991 [10.3%] with preserved ejection fraction, 592 [6.1%] with reduced ejection fraction, and 646 [6.7%] with unknown subtype).
For participants with HF at baseline, the hazard ratio (HR) for risk of the composite HF outcome with oral semaglutide vs placebo was 0.78 (95% CI, 0.63-0.96) and was 1.01 (95% CI, 0.84-1.20) in those without HF at baseline (P for interaction = .06).
In conclusion, CagriSema achieves greater weight loss than semaglutide or placebo but increases gastrointestinal adverse events, warranting careful tolerability monitoring and longer-term data.
Gadelmawla AF, Hammad N, Atta K, Diaa A, Abouzkaly F, Soni K, Kelkar R, Agrawal SP, Ahmed R, Jain H, Passey S, Aronow WS. · The American journal of cardiology (2026)
Pooled analysis showed that CagriSema significantly reduced percent weight loss (Cohen's d: -1.38; 95% CI: -1.84 to -0.91; I² = 94.8%).
Gastrointestinal adverse events were more frequent (RR: 1.32).
CagriSema also resulted in greater absolute weight loss (MD: -11 kg), waist circumference (MD: -9.41 cm), and systolic blood pressure (MD: -7.06 mmHg).
This regimen has enormous potential in dual-agonist therapy for obese patients.
Ahmed M, Hassan M, Tahir M, Hussain M, Islam F, Khan GT, Ahsan M, Bin Shafiq S, Ibrahim A, Uddin A, Waqas SA. · Diabetes, obesity & metabolism (2026)
Efficacy outcomes were percentage change in body weight, absolute change in body weight, fasting plasma glucose, HbA1c, and BMI.
A random-effects model was used to estimate mean differences (MD) or risk ratios (RR) with 95% CIs.
Cagrisema produced significantly greater percentage [MD -7.47% (95% CI: -10.58, -4.36); p < 0.001] and absolute [MD -7.60 kg (95% CI: -10.33, -4.86); p < 0.001] weight loss than semaglutide.
Lean mass loss during significant weight reduction is substantial, and the proportion of weight lost as lean mass is broadly comparable between incretin-based pharmacotherapy and lifestyle interventions.
Eisa N et al. · Diabetes, obesity & metabolism (2026)
Lean mass constituted 25%-39% of total weight lost with incretin agonists: semaglutide (35.2% [95% CI: 31.5-38.9]), tirzepatide (25.4% [22.8-28.0]) and liraglutide (26.8% [23.1-30.5]).
Lifestyle interventions showed comparable proportional lean mass loss (26.2% [24.1-28.3]; p = 0.42 for comparison), while lifestyle plus resistance training demonstrated the most favourable profile (17.5% [14.2-20.8]).
When compared to semaglutide, there were no significant differences in heart failure hospitalization or all-cause mortality.
Sebastian SA, Ayyalu T, Bimal T, Patel B, Kittleson MM, Carbone S, Yehya A. · Disease-a-month : DM (2026)
Tirzepatide was associated with a significant reduction in the composite outcome of cardiovascular mortality and worsening heart failure events compared with standard therapy (HR 0.50; 95% CI: 0.42-0.60; p < 0.001).
A significant reduction in heart failure exacerbation events alone was also observed with tirzepatide versus standard therapy (HR 0.75; p = 0.04), whereas no significant difference was seen when compared with semaglutide (HR 0.95; p = 0.31).
No statistically significant difference in adverse drug reactions was observed.
Optimal outcomes occur with lifestyle interventions at doses ≥2.4 mg weekly.
Zhang S, Niu S, An S, Cai X, Lao X. · European journal of pharmacology (2026)
Semaglutide significantly reduced absolute weight (WMD -12.24 kg, 95 % CI -13.25 to -11.22), percentage weight change (WMD -12.15 %, 95 % CI -13.63 to -10.67), BMI (WMD -4.32 kg/m 2 , 95 % CI -4.75 to -3.89), and waist circumference (WMD -9.32 cm, 95 % CI -9.87 to -8.78).
Semaglutide increased likelihood of achieving ≥5 % weight loss (RR 2.63, 95 % CI 2.12-3.25).
Total adverse events were modestly but significantly elevated (RR 1.05, 95 % CI 1.01-1.09), primarily gastrointestinal symptoms.
Mean percentage HbA1c was reduced by 1.8 percentage points with semaglutide 1.0 mg versus 1.4 percentage points with dulaglutide 1.5 mg (ETD -0.41 percentage points); bodyweight was reduced by 6.5 kg vs 3.0 kg.
Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. · Lancet Diabetes Endocrinol (2018)
Head-to-head open-label phase-3b RCT, 1,201 patients with type 2 diabetes on metformin, semaglutide vs dulaglutide at matched dose levels for 40 weeks
Semaglutide superior on HbA1c at both dose levels (e.g. -1.8 vs -1.4 percentage points at high dose; P<0.0001)
Greater weight loss: 6.5 kg vs 3.0 kg at the high doses (P<0.0001)
Estimated change in mean bodyweight from baseline to week 68 was -9.6% with semaglutide 2.4 mg vs -3.4% with placebo; treatment difference -6.2 percentage points.
Davies M, Færch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. · Lancet (2021)
Phase-3 RCT in 1,210 adults with overweight/obesity AND type 2 diabetes; semaglutide 2.4 mg vs 1.0 mg vs placebo for 68 weeks
Weight loss -9.6% (2.4 mg) vs -3.4% (placebo); difference -6.2 points (P<0.0001)
More patients achieved ≥5% weight loss (68.8% vs 28.5%; OR 4.88)
Major adverse cardiovascular events occurred in 61 of 1591 patients (3.8%) in the oral semaglutide group and 76 of 1592 (4.8%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.57 to 1.11; P<0.001 for noninferiority).
Husain M, Birkenfeld AL, Donsmark M, Dungan K, Eliaschewitz FG, Franco DR, Jeppesen OK, Lingvay I, Mosenzon O, Pedersen SD, Tack CJ, et al. · N Engl J Med (2019)
Cardiovascular-safety RCT of oral semaglutide in 3,183 patients with type 2 diabetes at high CV risk, median 15.9 months
MACE non-inferior to placebo (HR 0.79; 95% CI 0.57-1.11)
Lower cardiovascular death (HR 0.49) and all-cause death (HR 0.51) as secondary outcomes
Subcutaneous semaglutide was the most efficacious in reducing body weight followed by oral semaglutide... The same agents also conferred the greatest reductions in systolic blood pressure.
Tsapas A, Karagiannis T, Avgerinos I, Liakos A, Bekiari E, et al. · Diabetes Obes Metab (2021)
Network meta-analysis of 424 trials (276,336 patients) across 21 antidiabetic medications and 9 drug classes
Subcutaneous semaglutide ranked the most efficacious for body-weight reduction, followed by oral semaglutide
Semaglutide also produced the greatest systolic blood-pressure reductions
The mean weight change from baseline was -15.8% with semaglutide vs -6.4% with liraglutide (difference, -9.4 percentage points [95% CI, -12.0 to -6.8]; P < .001).
Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sørrig R, et al. · JAMA (2022)
Head-to-head RCT (338 adults, overweight/obesity without diabetes) of weekly semaglutide 2.4 mg vs daily liraglutide 3.0 mg for 68 weeks
Semaglutide produced markedly greater weight loss (-15.8% vs -6.4%; placebo -1.9%)
Higher odds of ≥10%, ≥15%, and ≥20% weight loss with semaglutide (e.g. ≥20%: 38.5% vs 6.0%)
With continued semaglutide, mean body weight change from week 20 to week 68 was -7.9% vs +6.9% with the switch to placebo (difference, -14.8 percentage points; P < .001).
Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, et al. · JAMA (2021)
Withdrawal-design RCT: after a 20-week semaglutide run-in (mean -10.6% weight), 803 participants continued semaglutide 2.4 mg or switched to placebo
Continued treatment kept losing weight (-7.9%) while placebo regained (+6.9%) — a 14.8-point difference
Demonstrates that benefit depends on ongoing use; weight regain follows discontinuation
Oral semaglutide reduced HbA1c (placebo-adjusted treatment differences at week 26: -0.6% [3 mg], -0.9% [7 mg], and -1.1% [14 mg]) and body weight.
Aroda VR, Rosenstock J, Terauchi Y, Altuntas Y, Lalic NM, Morales Villegas EC, Jeppesen OK, Christiansen E, Hertz CL, Haluzík M; PIONEER 1 Investigators. · Diabetes Care (2019)
Phase-3a RCT of the first oral GLP-1 agonist: 703 patients with type 2 diabetes on diet/exercise, oral semaglutide 3/7/14 mg daily vs placebo for 26 weeks
Dose-dependent HbA1c reduction (placebo-adjusted up to -1.1% to -1.4% by estimand)
Dose-dependent weight loss (up to -2.3 kg at 14 mg vs placebo)
These findings support its expanded use in non-diabetic CKD populations, including dialysis-dependent individuals.
Elganyny MKE, Elganyni AKE, Maskji HA, Ajaka N, Mishriki AES, Amin RSK, Abaza AOM, Elgokhy MM, Omair H, Esmaeil SFA, Abozaid HG, Elhagary AA, Ibrahim MM, El Ghafar MAA, Zidan MHS. · La Clinica terapeutica (2026)
Results Semaglutide treatment significantly reduced BMI (mean reduction: Tuttle 18.3%, Apperloo 11.8%, Vanek 1.5%; P = 0.001), and improved hypertension control (SBP <130 mmHg: Apperloo 20.6%, Vanek 12.5%, Tuttle 17.6%; P < 0.02).
Renal function also improved, with eGFR >30 ml/min/1.73m² increasing from baseline in all studies (Apperloo 65.8%, Vanek 4.83%, Tuttle 36.4%; P < 0.001).