Summary: In healthy Chinese adults, once-daily oral semaglutide (3 mg escalating to 14 mg over 12 weeks) significantly reduced body weight (p = .0001) and fasting plasma glucose (p = .0011) compared to placebo under identical study conditions, though it was associated with primarily gastrointestinal adverse events. PICO Description Population Healthy Chinese adults, 32 participants, randomized to receive either oral semaglutide or placebo for 12 weeks. Intervention Once-daily oral semaglutide (3 mg escalating to 14 mg) administered over 12 weeks to assess pharmacokinetics, pharmacodynamics, safety, and tolerability. Comparison Placebo group with identical study conditions to evaluate the treatment effect and…
Author: FWA
Summary: In adults with overweight or obesity participating in the STEP 1-4 Phase 3a trials over 68 weeks, once-weekly semaglutide 2.4 mg combined with lifestyle interventions significantly improved physical functioning and weight-related quality of life (WRQOL), with 51.8% meeting meaningful improvement thresholds compared to 28.3% on placebo (p<0.0001), compared to weekly placebo combined with lifestyle interventions. Health-related quality of life (HRQOL) improvements were noted, but some domains (e.g., SF-36v2 Role Emotional in STEP 2) showed no significant changes. PICO Description Population Adults with overweight or obesity participating in the STEP 1-4 Phase 3a trials, assessed over a 68-week period. Intervention…
Summary: In adults with preexisting cardiovascular disease, overweight or obesity, and no prior diagnosis of diabetes, semaglutide (GLP-1 receptor agonist) administered for up to 208 weeks significantly reduced body weight (-10.2%) compared to placebo (-1.5%), with anthropometric improvements in waist circumference (-7.7 cm) and waist-to-height ratio (-6.9%), and fewer serious adverse events but higher discontinuation rates, particularly in lower BMI categories. PICO Description Population Adults with preexisting cardiovascular disease, overweight or obesity, and no prior diagnosis of diabetes. Intervention Administration of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, for an extended period of up to 208 weeks to evaluate weight…
Summary: In patients with type 2 diabetes and chronic kidney disease (CKD), weekly semaglutide 1.0 mg for a median of 3.4 years significantly reduced the risk of major kidney events and death by 24%, slowed annual eGFR decline by 1.16 ml/min/1.73m², and lowered risks of death (20%) and cardiovascular events (18%) compared to placebo over the same duration, with fewer serious adverse events reported (49.6% vs. 53.8%). PICO Description Population Adults with overweight or obesity and established cardiovascular disease, without diabetes. Intervention Once-weekly administration of semaglutide 2.4 mg. Comparison Placebo administered once weekly. Outcome Semaglutide significantly reduced the incidence of…
PICO Description Population Patients with obesity-related heart failure with preserved ejection fraction (HFpEF), enrolled in the STEP-HFpEF program, involving 1,145 participants aged ≥18 years. Intervention Once-weekly semaglutide 2.4 mg administered for 52 weeks, aimed at improving New York Heart Association (NYHA) functional class, HF symptoms, and reducing bodyweight and inflammation markers. Comparison Placebo treatment provided under double-blind, randomized conditions for the same duration (52 weeks), across consistent baseline NYHA functional class categories. Outcome Semaglutide significantly improved NYHA functional class compared to placebo, with 32.6% of patients improving and fewer experiencing deterioration. Also, semaglutide improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores…
PICO Description Population Patients with type 2 diabetes and chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) of 50-75 ml/min/1.73m² with urinary albumin-to-creatinine ratio >300 to <5000 or eGFR of 25 to <50 ml/min/1.73m² with urinary albumin-to-creatinine ratio >100 to <5000. Intervention Weekly subcutaneous injection of semaglutide at a dose of 1.0 mg, with a follow-up over a median of 3.4 years. Comparison Placebo administered weekly with the same follow-up duration. Outcome Semaglutide reduced the risk of a primary outcome event (major kidney events and death from kidney-related or cardiovascular causes) by 24% compared to placebo. Participants…
Summary: In patients with obesity-related heart failure with preserved ejection fraction (HFpEF) enrolled in the STEP-HFpEF trials (n=1,145), weekly semaglutide 2.4 mg significantly reduced NT-proBNP levels, improved health status (up to 11.9 points in KCCQ), and achieved consistent weight loss compared to placebo under identical conditions. PICO Description Population Patients with obesity-related heart failure with preserved ejection fraction (HFpEF), enrolled in the STEP-HFpEF and STEP-HFpEF DM trials; total of 1,145 participants. Intervention Administration of semaglutide 2.4 mg weekly to examine reductions in NT-proBNP levels, health status improvements, and weight loss. Comparison Placebo-controlled group used to evaluate semaglutide’s efficacy on NT-proBNP…
Summary: In 1,879 adults with type 2 diabetes participating in the SURPASS-2 phase 3 trial conducted across 128 sites in 8 countries, once-weekly subcutaneous tirzepatide at doses of 5 mg, 10 mg, or 15 mg for 40 weeks significantly improved markers of β-cell function, insulin sensitivity, and fasting biomarkers, with greater reductions in HbA1c and weight compared to semaglutide 1 mg administered weekly under similar trial conditions for 40 weeks. Efficacy of tirzepatide was consistent regardless of baseline β-cell function and insulin resistance. PICO Description Population A total of 1,879 adult participants with type 2 diabetes who were part of…
Summary: In adults with early-onset type 2 diabetes (T2D) compared to those with later-onset T2D in a post hoc analysis of the SURPASS clinical trials (n=3,792), tirzepatide, a dual GIP and GLP-1 receptor agonist, administered over 40–52 weeks significantly improved HbA1c (-2.6% vs. -2.4%), body weight (-14 kg vs. -13 kg), waist circumference (-10 cm vs. -10 cm), triglycerides (-26% vs. -24%), HDL cholesterol (+7% vs. +7%), and systolic blood pressure (-6 mmHg vs. -7 mmHg) compared to individuals with later-onset T2D receiving tirzepatide under identical settings, though early-onset T2D individuals exhibited worse metabolic profiles at baseline. Tirzepatide demonstrated robust…
Summary: In overweight or obese adults with type 2 diabetes (T2DM) and non-alcoholic fatty liver disease (NAFLD), combination therapy of semaglutide (GLP-1 receptor agonist) and empagliflozin (SGLT-2 inhibitor) administered over 52 weeks significantly improved liver fat reduction (as assessed by controlled attenuation parameter), liver enzyme levels, blood glucose control, and lipid profiles compared to monotherapy using either semaglutide or empagliflozin individually for the same duration, with safety and tolerability analyses supporting the use of the combination treatment. PICO Description Population Overweight or obese adults with type 2 diabetes (T2DM) and non-alcoholic fatty liver disease (NAFLD). Intervention Combination therapy of semaglutide…