The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

NCT06606821 | Recruiting Phase 4

• 1 other identifier: 2023-505270-15-00
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.

Conditions

Coronary Artery Disease; Coronary Microvascular Dysfunction; Overweight or Obesity; Stable Angina Pectoris; Chronic Coronary Artery Disease; Atherosclerosis Cardiovascular Disease

Keywords

NIRS; IVUS; GLP-1; Tirzepatide; Intravascular imagining; Stable Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Lipid core burden index

  Lipid core burden index of the three major coronary vessels (LCBItotal) measured by NIRS imaging.

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

Secondary Outcomes (3)

• Percent atheroma volume (PAV)

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

• Number of high-risk coronary lesion

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

• Coronary flow reserve

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

Other Outcomes (19)

• Plasma lipid profile

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

• Markers of inflammation

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

• Left ventricular systolic and diastolic function assessed by echocardiography:

  Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Tirzepatide is administered sc. once-weekly.

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Placebo is administered sc. once-weekly.

Drug: Placebo

Interventions

Tirzepatide DRUG

Investigational drug will be administered as a sc. injection once-weekly.

Also known as: LY3298176

Tirzepatide

Placebo DRUG

Placebo containing the same excipients and volume as the active treatment arm but without tirzepatide will be administered as a sc. injection once-weekly.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed written consent
• BMI equal to or above 27 kg/m2
• Age 18 years or older
• Referred to coronary angiogram (CAG) due to stable angina
• Coronary atheromatosis by angiography (obstructive or non-obstructive)
• LCBI4mm \>200 by NIRS in a vessel not subjected to coronary intervention

You may not qualify if:

• History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline
• Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)
• History of coronary artery bypass surgery (CABG)
• Planned CV intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation
• History of heart failure New York Heart Association (NYHA) class III or IV
• Left ventricular ejection fraction (LVEF) ≤35%
• eGFR \<30 ml/min/1.53 m2
• History of pancreatitis or plasma amylase \>2 times upper normal limit
• Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal)
• Pregnancy, planned pregnancy or breastfeeding
• Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)
• Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients
• Left main stenosis (≥50% diameter or haemodynamically significant)
• Chronic total occlusion of any major coronary vessel
• Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery

Sponsors & Collaborators

• Tina Vilsbøll: lead

Study Sites (3)

Rigshospitalet

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Gentofte Hospital

Gentofte Municipality, 2900, Denmark

RECRUITING

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

Related Publications (39)

• Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.

  PMID: 35658024 BACKGROUND

• Stoner MCD, Bhushan NL, Maragh-Bass AC, Mitchell JT, Riggins L, Walker M, LeMasters K, Reese B, Dearing A, Debnam S, Golin C, Lightfoot AF, Pettifor A. Using Participatory Methods to Assess PrEP Interest and Uptake Among Young People Living in the Southeastern US: A Mixed Methods Assessment. AIDS Behav. 2022 May;26(5):1672-1683. doi: 10.1007/s10461-021-03519-y. Epub 2021 Nov 1.

  PMID: 34724592 BACKGROUND

• Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.

  PMID: 30473097 BACKGROUND

• Frias JP, Nauck MA, Van J, Kutner ME, Cui X, Benson C, Urva S, Gimeno RE, Milicevic Z, Robins D, Haupt A. Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. Lancet. 2018 Nov 17;392(10160):2180-2193. doi: 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4.

  PMID: 30293770 BACKGROUND

• Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.

  PMID: 34170647 BACKGROUND

• Kristensen SL, Rorth R, Jhund PS, Docherty KF, Sattar N, Preiss D, Kober L, Petrie MC, McMurray JJV. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet Diabetes Endocrinol. 2019 Oct;7(10):776-785. doi: 10.1016/S2213-8587(19)30249-9. Epub 2019 Aug 14.

  PMID: 31422062 BACKGROUND

• Caruso I, Cignarelli A, Giorgino F. Heterogeneity and Similarities in GLP-1 Receptor Agonist Cardiovascular Outcomes Trials. Trends Endocrinol Metab. 2019 Sep;30(9):578-589. doi: 10.1016/j.tem.2019.07.004. Epub 2019 Aug 7.

  PMID: 31401015 BACKGROUND

• ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 6. Glycemic Targets: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S97-S110. doi: 10.2337/dc23-S006.

  PMID: 36507646 BACKGROUND

• Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

  PMID: 31189511 BACKGROUND

• Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.

  PMID: 30291013 BACKGROUND

• Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

  PMID: 27295427 BACKGROUND

• Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.

  PMID: 27633186 BACKGROUND

• Oh J, Teoh H, Leiter LA. Should C-reactive protein be a target of therapy? Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S155-60. doi: 10.2337/dc11-s211. No abstract available.

  PMID: 21525448 BACKGROUND

• Howard G, Wagenknecht LE, Burke GL, Diez-Roux A, Evans GW, McGovern P, Nieto FJ, Tell GS. Cigarette smoking and progression of atherosclerosis: The Atherosclerosis Risk in Communities (ARIC) Study. JAMA. 1998 Jan 14;279(2):119-24. doi: 10.1001/jama.279.2.119.

  PMID: 9440661 BACKGROUND

• Mundi S, Massaro M, Scoditti E, Carluccio MA, van Hinsbergh VWM, Iruela-Arispe ML, De Caterina R. Endothelial permeability, LDL deposition, and cardiovascular risk factors-a review. Cardiovasc Res. 2018 Jan 1;114(1):35-52. doi: 10.1093/cvr/cvx226.

  PMID: 29228169 BACKGROUND

• Bai X, Yang X, Jia X, Rong Y, Chen L, Zeng T, Deng X, Li W, Wu G, Wang L, Li Y, Zhang J, Xiong Z, Xiong L, Wang Y, Zhu L, Zhao Y, Jin S. CAV1-CAVIN1-LC3B-mediated autophagy regulates high glucose-stimulated LDL transcytosis. Autophagy. 2020 Jun;16(6):1111-1129. doi: 10.1080/15548627.2019.1659613. Epub 2019 Sep 4.

  PMID: 31448673 BACKGROUND

• Langheim S, Dreas L, Veschini L, Maisano F, Foglieni C, Ferrarello S, Sinagra G, Zingone B, Alfieri O, Ferrero E, Maseri A, Ruotolo G. Increased expression and secretion of resistin in epicardial adipose tissue of patients with acute coronary syndrome. Am J Physiol Heart Circ Physiol. 2010 Mar;298(3):H746-53. doi: 10.1152/ajpheart.00617.2009. Epub 2010 Jan 8.

  PMID: 20061546 BACKGROUND

• Boren J, Chapman MJ, Krauss RM, Packard CJ, Bentzon JF, Binder CJ, Daemen MJ, Demer LL, Hegele RA, Nicholls SJ, Nordestgaard BG, Watts GF, Bruckert E, Fazio S, Ference BA, Graham I, Horton JD, Landmesser U, Laufs U, Masana L, Pasterkamp G, Raal FJ, Ray KK, Schunkert H, Taskinen MR, van de Sluis B, Wiklund O, Tokgozoglu L, Catapano AL, Ginsberg HN. Low-density lipoproteins cause atherosclerotic cardiovascular disease: pathophysiological, genetic, and therapeutic insights: a consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2020 Jun 21;41(24):2313-2330. doi: 10.1093/eurheartj/ehz962. No abstract available.

  PMID: 32052833 BACKGROUND

• Piche ME, Tchernof A, Despres JP. Obesity Phenotypes, Diabetes, and Cardiovascular Diseases. Circ Res. 2020 May 22;126(11):1477-1500. doi: 10.1161/CIRCRESAHA.120.316101. Epub 2020 May 21.

  PMID: 32437302 BACKGROUND

• Kim SH, Despres JP, Koh KK. Obesity and cardiovascular disease: friend or foe? Eur Heart J. 2016 Dec 21;37(48):3560-3568. doi: 10.1093/eurheartj/ehv509. Epub 2015 Dec 18.

  PMID: 26685971 BACKGROUND

• Hou J, Renigunta A, Konrad M, Gomes AS, Schneeberger EE, Paul DL, Waldegger S, Goodenough DA. Claudin-16 and claudin-19 interact and form a cation-selective tight junction complex. J Clin Invest. 2008 Feb;118(2):619-28. doi: 10.1172/JCI33970.

  PMID: 18188451 BACKGROUND

• Nakamura K, Fuster JJ, Walsh K. Adipokines: a link between obesity and cardiovascular disease. J Cardiol. 2014 Apr;63(4):250-9. doi: 10.1016/j.jjcc.2013.11.006. Epub 2013 Dec 16.

  PMID: 24355497 BACKGROUND

• Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.

  PMID: 14679176 BACKGROUND

• Kang SJ, Mintz GS, Pu J, Sum ST, Madden SP, Burke AP, Xu K, Goldstein JA, Stone GW, Muller JE, Virmani R, Maehara A. Combined IVUS and NIRS detection of fibroatheromas: histopathological validation in human coronary arteries. JACC Cardiovasc Imaging. 2015 Feb;8(2):184-94. doi: 10.1016/j.jcmg.2014.09.021. Epub 2015 Jan 7.

  PMID: 25577445 BACKGROUND

• Negi SI, Didier R, Ota H, Magalhaes MA, Popma CJ, Kollmer MR, Spad MA, Torguson R, Suddath W, Satler LF, Pichard A, Waksman R. Role of near-infrared spectroscopy in intravascular coronary imaging. Cardiovasc Revasc Med. 2015 Jul-Aug;16(5):299-305. doi: 10.1016/j.carrev.2015.06.001. Epub 2015 Jun 10.

  PMID: 26242984 BACKGROUND

• Chen S, Okahara F, Osaki N, Shimotoyodome A. Increased GIP signaling induces adipose inflammation via a HIF-1alpha-dependent pathway and impairs insulin sensitivity in mice. Am J Physiol Endocrinol Metab. 2015 Mar 1;308(5):E414-25. doi: 10.1152/ajpendo.00418.2014. Epub 2014 Dec 23.

  PMID: 25537494 BACKGROUND

• Otake H, Tanimura K, Sugizaki Y, Toba T, Kawamori H, Shinke T, Hirata KI. Effect of Alirocumab and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaque in Coronary Artery Disease Seen on Near-Infrared Spectroscopy Intravascular Ultrasound (ANTARES). Circ Rep. 2019 Jan 31;1(2):107-111. doi: 10.1253/circrep.CJ-18-0021.

  PMID: 33693121 BACKGROUND

• Honda S, Sidharta SL, Shishikura D, Takata K, Di Giovanni GA, Nguyen T, Janssan A, Kim SW, Andrews J, Psaltis PJ, Worthley MI, Nicholls SJ. High-density lipoprotein cholesterol associated with change in coronary plaque lipid burden assessed by near infrared spectroscopy. Atherosclerosis. 2017 Oct;265:110-116. doi: 10.1016/j.atherosclerosis.2017.08.016. Epub 2017 Aug 31.

  PMID: 28881268 BACKGROUND

• Kini AS, Vengrenyuk Y, Shameer K, Maehara A, Purushothaman M, Yoshimura T, Matsumura M, Aquino M, Haider N, Johnson KW, Readhead B, Kidd BA, Feig JE, Krishnan P, Sweeny J, Milind M, Moreno P, Mehran R, Kovacic JC, Baber U, Dudley JT, Narula J, Sharma S. Intracoronary Imaging, Cholesterol Efflux, and Transcriptomes After Intensive Statin Treatment: The YELLOW II Study. J Am Coll Cardiol. 2017 Feb 14;69(6):628-640. doi: 10.1016/j.jacc.2016.10.029. Epub 2016 Oct 29.

  PMID: 27989886 BACKGROUND

• Kini AS, Baber U, Kovacic JC, Limaye A, Ali ZA, Sweeny J, Maehara A, Mehran R, Dangas G, Mintz GS, Fuster V, Narula J, Sharma SK, Moreno PR. Changes in plaque lipid content after short-term intensive versus standard statin therapy: the YELLOW trial (reduction in yellow plaque by aggressive lipid-lowering therapy). J Am Coll Cardiol. 2013 Jul 2;62(1):21-9. doi: 10.1016/j.jacc.2013.03.058. Epub 2013 May 1.

  PMID: 23644090 BACKGROUND

• Biccire FG, Budassi S, Ozaki Y, Boi A, Romagnoli E, Di Pietro R, Bourantas CV, Marco V, Paoletti G, Debelak C, Sammartini E, Versaci F, Fabbiocchi F, Burzotta F, Pastori D, Crea F, Arbustini E, Alfonso F, Prati F. Optical coherence tomography-derived lipid core burden index and clinical outcomes: results from the CLIMA registry. Eur Heart J Cardiovasc Imaging. 2023 Mar 21;24(4):437-445. doi: 10.1093/ehjci/jeac110.

  PMID: 35718858 BACKGROUND

• NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19.2 million participants. Lancet. 2016 Apr 2;387(10026):1377-1396. doi: 10.1016/S0140-6736(16)30054-X.

  PMID: 27115820 BACKGROUND

• Adair T, Lopez AD. The role of overweight and obesity in adverse cardiovascular disease mortality trends: an analysis of multiple cause of death data from Australia and the USA. BMC Med. 2020 Aug 4;18(1):199. doi: 10.1186/s12916-020-01666-y.

  PMID: 32746822 BACKGROUND

• Patel D, Hamamdzic D, Llano R, Patel D, Cheng L, Fenning RS, Bannan K, Wilensky RL. Subsequent development of fibroatheromas with inflamed fibrous caps can be predicted by intracoronary near infrared spectroscopy. Arterioscler Thromb Vasc Biol. 2013 Feb;33(2):347-53. doi: 10.1161/ATVBAHA.112.300710. Epub 2013 Jan 3.

  PMID: 23288155 BACKGROUND

• Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1262-75. doi: 10.1161/01.atv.20.5.1262. No abstract available.

  PMID: 10807742 BACKGROUND

• Lopez AD, Adair T. Is the long-term decline in cardiovascular-disease mortality in high-income countries over? Evidence from national vital statistics. Int J Epidemiol. 2019 Dec 1;48(6):1815-1823. doi: 10.1093/ije/dyz143.

  PMID: 31378814 BACKGROUND

• Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

  PMID: 33309175 BACKGROUND

• Raber L, Taniwaki M, Zaugg S, Kelbaek H, Roffi M, Holmvang L, Noble S, Pedrazzini G, Moschovitis A, Luscher TF, Matter CM, Serruys PW, Juni P, Garcia-Garcia HM, Windecker S; IBIS 4 (Integrated Biomarkers and Imaging Study-4) Trial Investigators (NCT00962416). Effect of high-intensity statin therapy on atherosclerosis in non-infarct-related coronary arteries (IBIS-4): a serial intravascular ultrasonography study. Eur Heart J. 2015 Feb 21;36(8):490-500. doi: 10.1093/eurheartj/ehu373. Epub 2014 Sep 2.

  PMID: 25182248 BACKGROUND

• Weisbrod RM, Shiang T, Al Sayah L, Fry JL, Bajpai S, Reinhart-King CA, Lob HE, Santhanam L, Mitchell G, Cohen RA, Seta F. Arterial stiffening precedes systolic hypertension in diet-induced obesity. Hypertension. 2013 Dec;62(6):1105-10. doi: 10.1161/HYPERTENSIONAHA.113.01744. Epub 2013 Sep 23.

  PMID: 24060894 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Overweight; Obesity; Angina, Stable

Interventions

Tirzepatide; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tina Vilsbøll, MD, DMSc

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Raaschou-Oddershede, MD

CONTACT

+4520157448; daniel.raaschou-oddershede@regionh.dk

Christine Rode Schwarz, MD, PhD

CONTACT

christine.rode.schwarz@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD DMSc

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 1 year after the end of the trial and publication of the primary outcomes, and will be available for 24 months.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to Prof. Tina Vilsbøll, MD DMSc, at tina.vilsboell.01@regionh.dk. To gain access, data requestors will need to sign a data access agreement.

Locations

DK (3)