{"doi":"10.2337/db25-1978-lb","title":"1978-LB: Efficacy and Safety of Semaglutide 7.2 mg in Obesity and Type 2 Diabetes—STEP UP T2D Trial","abstract":"<jats:p>Introduction and Objective: To assess efficacy and safety of semaglutide (sema) 7.2 mg in adults with obesity and T2D.</jats:p>\n               <jats:p>Methods: In a multicenter, double-blind trial (NCT05649137), participants with BMI ≥30 kg/m2 and T2D were randomized 3:1:1 to once-weekly s.c. sema 7.2 mg, 2.4 mg, or placebo (pbo), plus lifestyle intervention for 72 weeks with 9-week follow-up. Co-primary endpoints were weight loss (WL; %) and proportions reaching WL ≥5%; confirmatory endpoints were WL ≥10%, ≥15%, and ≥20%; waist circumference (WC) change (cm); and HbA1c change (%); all for sema 7.2 mg vs pbo (treatment policy estimand). Safety was assessed.</jats:p>\n               <jats:p>Results: Baseline characteristics (N=512) were: female 52%; mean age 56 yrs; body weight 110 kg; BMI 38.6 kg/m2; WC 122 cm; HbA1c 8.1%. Sema 7.2 mg led to greater WL vs pbo (−13.2% vs −3.9%; p&amp;lt;0.001) and vs sema 2.4 mg (−13.2% vs −10.4%; post hoc p=0.003; Fig.). More participants reached WL thresholds with sema 7.2 mg (all p&amp;lt;0.001; Fig.) and had greater reductions in WC (estimated treatment difference [ETD; 95% CI]: −6.5 [−9.0, −4.1]; p&amp;lt;0.001) and HbA1c (ETD [95% CI]: −1.5 [−1.8, −1.2]; p&amp;lt;0.001) vs pbo. Gastrointestinal adverse events (AEs) were reported by 53.1%, 51.5%, and 25.5% of participants with sema 7.2 mg, 2.4 mg, and pbo, and serious AEs by 9.1%, 8.7%, and 8.8%, respectively. Sema 7.2 mg did not increase hypoglycemic episode risk vs 2.4 mg or pbo.</jats:p>\n               <jats:p>Conclusion: Sema 7.2 mg led to greater WL vs comparators, with a safety profile comparable to sema 2.4 mg.</jats:p>\n               <jats:p/>\n               <jats:sec>\n                  <jats:title>Disclosure</jats:title>\n                  <jats:p>I. Lingvay: Consultant; Abbvie, Altimmune, Amgen, Alveus Tx, Antag Tx, Astra Zeneca, Bayer, Betagenon AB, Bioio Inc., Biomea, Boehringer-Ingelheim, Carmot, Cytoki Pharma, Eli Lilly, Intercept, Janssen/J&amp;J, Juvena, Keros Ther, Novo Nordisk, Pharmaventures, Pfizer, Regeneron, Roche, Sanofi, Shionogi, Source Bio, Structure Therapeutics, TARGET RWE, TERNS Pharma, The Comm Group, WebMD, and Zealand Pharma. Research Support; Novo Nordisk, Sanofi, Boehringer-Ingelheim. S.J. Bergenheim: Employee; Novo Nordisk A/S. J.B. Buse: Other Relationship; Corcept Therapeutics, Dexcom, Inc., Novo Nordisk. Consultant; Altimmune Inc, Amgen Inc, ApStem, Aqua Medical, AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio. Other Relationship; Glyscend Therapeutics. Consultant; Insulet Corporation, Medtronic. Other Relationship; Mellitus Health. Consultant; Metsera. Other Relationship; Pendulum Therapeutics, Praetego, Stability Health. Consultant; Tandem Diabetes Care, Inc, TERNS Pharmaceuticals, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. P. Freitas: Speaker's Bureau; Eli Lilly and Company, Bayer Pharmaceuticals, Inc, Roche Diagnostics, Novo Nordisk, Merck Sharp &amp; Dohme Corp, Sanofi, Medinfar Portugal, Bial, NKPS Protein Suppleis, Faes Farma. W. Garvey: Advisory Panel; Boehringer-Ingelheim, Eli Lilly and Company, Novo Nordisk, Fractyl Health, Inc., Alnylam Pharmaceuticals, Inc, Zealand Pharma A/S, Allurion, Carmot Therapeutics, Inc, TERNS Pharmaceuticals, Regeneron Pharmaceuticals, Inogen, Neurocrine, Keros Therapeutics. Research Support; Novo Nordisk, Eli Lilly and Company, Epitomee, Neurovalens, Roche Pharmaceuticals, Zealand Pharma A/S. N.M. Harder-Lauridsen: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. J. Rosenstock: Advisory Panel; Amgen Inc. Research Support; Amgen Inc. Advisory Panel; Applied Therapeutics. Research Support; Applied Therapeutics, AstraZeneca. Advisory Panel; Bayer Pharmaceuticals, Inc, Biomea Fusion, Corcept Therapeutics, Eli Lilly and Company. Research Support; Eli Lilly and Company. Advisory Panel; Hanmi Pharm. Co., Ltd. Research Support; Merck &amp; Co., Inc, Novartis AG. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Advisory Panel; Regeneron Pharmaceuticals. Research Support; Regeneron Pharmaceuticals, Regeneron Pharmaceuticals. Advisory Panel; Regor Therapeutics, Roche Pharmaceuticals, Sanofi. Research Support; Sanofi. Advisory Panel; Structure Therapeutics, Inc, Zealand Pharma A/S. K. Sahu: Employee; Novo Nordisk A/S. S. Wharton: Advisory Panel; Novo Nordisk A/S, Eli Lilly and Company, Boehringer-Ingelheim, AstraZeneca, Amgen Inc, Biohaven.</jats:p>\n               </jats:sec>","journal":"Diabetes","year":2025,"id":603523,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1548179,"name":"SARA J. BERGENHEIM","orcid":null,"position":1,"is_corresponding":false},{"id":1548180,"name":"JOHN B. BUSE","orcid":null,"position":2,"is_corresponding":false},{"id":1548181,"name":"PAULA FREITAS","orcid":null,"position":3,"is_corresponding":false},{"id":1548182,"name":"W. TIMOTHY (TIM) GARVEY","orcid":null,"position":4,"is_corresponding":false},{"id":1548183,"name":"NINA M. HARDER-LAURIDSEN","orcid":null,"position":5,"is_corresponding":false},{"id":1548184,"name":"JULIO ROSENSTOCK","orcid":null,"position":6,"is_corresponding":false},{"id":1548186,"name":"KUSHAL SAHU","orcid":null,"position":7,"is_corresponding":false},{"id":1548188,"name":"SEAN WHARTON","orcid":null,"position":8,"is_corresponding":false},{"id":1548178,"name":"ILDIKO LINGVAY","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"1978-LB: Efficacy and Safety of Semaglutide 7.2 mg in Obesity and Type 2 Diabetes—STEP UP T2D Trial","abstract":"<jats:p>Introduction and Objective: To assess efficacy and safety of semaglutide (sema) 7.2 mg in adults with obesity and T2D.</jats:p>\n               <jats:p>Methods: In a multicenter, double-blind trial (NCT05649137), participants with BMI ≥30 kg/m2 and T2D were randomized 3:1:1 to once-weekly s.c. sema 7.2 mg, 2.4 mg, or placebo (pbo), plus lifestyle intervention for 72 weeks with 9-week follow-up. Co-primary endpoints were weight loss (WL; %) and proportions reaching WL ≥5%; confirmatory endpoints were WL ≥10%, ≥15%, and ≥20%; waist circumference (WC) change (cm); and HbA1c change (%); all for sema 7.2 mg vs pbo (treatment policy estimand). Safety was assessed.</jats:p>\n               <jats:p>Results: Baseline characteristics (N=512) were: female 52%; mean age 56 yrs; body weight 110 kg; BMI 38.6 kg/m2; WC 122 cm; HbA1c 8.1%. Sema 7.2 mg led to greater WL vs pbo (−13.2% vs −3.9%; p&amp;lt;0.001) and vs sema 2.4 mg (−13.2% vs −10.4%; post hoc p=0.003; Fig.). More participants reached WL thresholds with sema 7.2 mg (all p&amp;lt;0.001; Fig.) and had greater reductions in WC (estimated treatment difference [ETD; 95% CI]: −6.5 [−9.0, −4.1]; p&amp;lt;0.001) and HbA1c (ETD [95% CI]: −1.5 [−1.8, −1.2]; p&amp;lt;0.001) vs pbo. Gastrointestinal adverse events (AEs) were reported by 53.1%, 51.5%, and 25.5% of participants with sema 7.2 mg, 2.4 mg, and pbo, and serious AEs by 9.1%, 8.7%, and 8.8%, respectively. Sema 7.2 mg did not increase hypoglycemic episode risk vs 2.4 mg or pbo.</jats:p>\n               <jats:p>Conclusion: Sema 7.2 mg led to greater WL vs comparators, with a safety profile comparable to sema 2.4 mg.</jats:p>\n               <jats:p/>\n               <jats:sec>\n                  <jats:title>Disclosure</jats:title>\n                  <jats:p>I. Lingvay: Consultant; Abbvie, Altimmune, Amgen, Alveus Tx, Antag Tx, Astra Zeneca, Bayer, Betagenon AB, Bioio Inc., Biomea, Boehringer-Ingelheim, Carmot, Cytoki Pharma, Eli Lilly, Intercept, Janssen/J&amp;J, Juvena, Keros Ther, Novo Nordisk, Pharmaventures, Pfizer, Regeneron, Roche, Sanofi, Shionogi, Source Bio, Structure Therapeutics, TARGET RWE, TERNS Pharma, The Comm Group, WebMD, and Zealand Pharma. Research Support; Novo Nordisk, Sanofi, Boehringer-Ingelheim. S.J. Bergenheim: Employee; Novo Nordisk A/S. J.B. Buse: Other Relationship; Corcept Therapeutics, Dexcom, Inc., Novo Nordisk. Consultant; Altimmune Inc, Amgen Inc, ApStem, Aqua Medical, AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio. Other Relationship; Glyscend Therapeutics. Consultant; Insulet Corporation, Medtronic. Other Relationship; Mellitus Health. Consultant; Metsera. Other Relationship; Pendulum Therapeutics, Praetego, Stability Health. Consultant; Tandem Diabetes Care, Inc, TERNS Pharmaceuticals, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. P. Freitas: Speaker's Bureau; Eli Lilly and Company, Bayer Pharmaceuticals, Inc, Roche Diagnostics, Novo Nordisk, Merck Sharp &amp; Dohme Corp, Sanofi, Medinfar Portugal, Bial, NKPS Protein Suppleis, Faes Farma. W. Garvey: Advisory Panel; Boehringer-Ingelheim, Eli Lilly and Company, Novo Nordisk, Fractyl Health, Inc., Alnylam Pharmaceuticals, Inc, Zealand Pharma A/S, Allurion, Carmot Therapeutics, Inc, TERNS Pharmaceuticals, Regeneron Pharmaceuticals, Inogen, Neurocrine, Keros Therapeutics. Research Support; Novo Nordisk, Eli Lilly and Company, Epitomee, Neurovalens, Roche Pharmaceuticals, Zealand Pharma A/S. N.M. Harder-Lauridsen: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. J. Rosenstock: Advisory Panel; Amgen Inc. Research Support; Amgen Inc. Advisory Panel; Applied Therapeutics. Research Support; Applied Therapeutics, AstraZeneca. Advisory Panel; Bayer Pharmaceuticals, Inc, Biomea Fusion, Corcept Therapeutics, Eli Lilly and Company. Research Support; Eli Lilly and Company. Advisory Panel; Hanmi Pharm. Co., Ltd. Research Support; Merck &amp; Co., Inc, Novartis AG. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Advisory Panel; Regeneron Pharmaceuticals. Research Support; Regeneron Pharmaceuticals, Regeneron Pharmaceuticals. Advisory Panel; Regor Therapeutics, Roche Pharmaceuticals, Sanofi. Research Support; Sanofi. Advisory Panel; Structure Therapeutics, Inc, Zealand Pharma A/S. K. Sahu: Employee; Novo Nordisk A/S. S. Wharton: Advisory Panel; Novo Nordisk A/S, Eli Lilly and Company, Boehringer-Ingelheim, AstraZeneca, Amgen Inc, Biohaven.</jats:p>\n               </jats:sec>","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"23304386","pmcid":null,"openalex_id":"https://openalex.org/W4411291192","authors":[],"funders":[],"total_grants":0,"fwci":0.0,"citation_percentile":0.17937882,"influential_citations":0,"citation_trend":[],"oa_status":"closed","license":"http://www.diabetesjournals.org/content/license","oa_locations":[{"url":"https://diabetesjournals.org/diabetes/article/74/Supplement_1/1978-LB/159786/1978-LB-Efficacy-and-Safety-of-Semaglutide-7-2-mg","host_type":"publisher"},{"url":"https://doi.org/10.2337/db25-1978-lb","host_type":"journal"}],"fields_of_study":["Diabetes Treatment and Management","Metabolism, Diabetes, and Cancer","Cancer Treatment and Pharmacology"],"mesh_terms":[],"keywords":["Semaglutide","Type 2 diabetes","Medicine","Obesity","Diabetes mellitus","Internal medicine","Endocrinology"],"sdg_mappings":[],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-29T22:09:44.130957Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}