A randomized, placebo‐controlled trial of beloranib for the treatment of hypothalamic injury‐associated obesity
Aims Hypothalamic injury‐associated obesity (HIAO) results from damage to the hypothalamus that often occurs with surgical removal/radiation therapy of tumours in the hypothalamic region, such as craniopharyngioma. There is currently no rigorously studied pharmaceutical treatment for the intractable...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2017-08, Vol.19 (8), p.1165-1170 |
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| creator | Shoemaker, Ashley Proietto, Joseph Abuzzahab, M. Jennifer Markovic, Tania Malloy, Jaret Kim, Dennis D. |
| description | Aims
Hypothalamic injury‐associated obesity (HIAO) results from damage to the hypothalamus that often occurs with surgical removal/radiation therapy of tumours in the hypothalamic region, such as craniopharyngioma. There is currently no rigorously studied pharmaceutical treatment for the intractable weight gain and cardiometabolic consequences that occur in patients with HIAO. We aimed to assess efficacy, safety and tolerability of beloranib treatment for 4 to 8 weeks in patients with HIAO.
Materials and methods
This Phase 2a, double‐blind, placebo‐controlled study included 14 patients with HIAO, randomized to receive beloranib 1.8 mg or placebo subcutaneously twice weekly for 4 weeks with an optional 4‐week open‐label extension in which all patients received beloranib. The primary endpoint was change in weight from baseline to Week 4.
Results
Participants were 64% female, with a mean (SD) age of 32 (9) years, BMI of 43 (7) kg/m2 and weight of 126 (22) kg. Compared with placebo (N = 4), beloranib 1.8 mg (N = 8) resulted in a mean (95% CI) difference in weight of −3.2 (−5.4, −0.9) kg after 4 weeks. Weight loss continued through the 8 weeks in patients randomized to beloranib (mean −6.2 [−8.2, −4.1] kg). Beloranib treatment was associated with improvements in high‐sensitivity CRP. Adverse events were mild to moderate. No patients who received beloranib discontinued treatment.
Conclusion
Beloranib treatment resulted in progressive weight loss in patients with HIAO that was comparable to that observed with beloranib in patients with exogenous obesity. These findings indicate a novel mechanism for treating obesity in patients with HIAO. |
| doi_str_mv | 10.1111/dom.12928 |
| format | Article |
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Hypothalamic injury‐associated obesity (HIAO) results from damage to the hypothalamus that often occurs with surgical removal/radiation therapy of tumours in the hypothalamic region, such as craniopharyngioma. There is currently no rigorously studied pharmaceutical treatment for the intractable weight gain and cardiometabolic consequences that occur in patients with HIAO. We aimed to assess efficacy, safety and tolerability of beloranib treatment for 4 to 8 weeks in patients with HIAO.
Materials and methods
This Phase 2a, double‐blind, placebo‐controlled study included 14 patients with HIAO, randomized to receive beloranib 1.8 mg or placebo subcutaneously twice weekly for 4 weeks with an optional 4‐week open‐label extension in which all patients received beloranib. The primary endpoint was change in weight from baseline to Week 4.
Results
Participants were 64% female, with a mean (SD) age of 32 (9) years, BMI of 43 (7) kg/m2 and weight of 126 (22) kg. Compared with placebo (N = 4), beloranib 1.8 mg (N = 8) resulted in a mean (95% CI) difference in weight of −3.2 (−5.4, −0.9) kg after 4 weeks. Weight loss continued through the 8 weeks in patients randomized to beloranib (mean −6.2 [−8.2, −4.1] kg). Beloranib treatment was associated with improvements in high‐sensitivity CRP. Adverse events were mild to moderate. No patients who received beloranib discontinued treatment.
Conclusion
Beloranib treatment resulted in progressive weight loss in patients with HIAO that was comparable to that observed with beloranib in patients with exogenous obesity. These findings indicate a novel mechanism for treating obesity in patients with HIAO.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.12928</identifier><identifier>PMID: 28261955</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject><![CDATA[Adult ; Aminopeptidases - antagonists & inhibitors ; Aminopeptidases - metabolism ; antiobesity drug ; appetite control ; Appetite Depressants - administration & dosage ; Appetite Depressants - adverse effects ; Appetite Depressants - therapeutic use ; Biomarkers - blood ; Body Mass Index ; Cardiovascular Diseases - epidemiology ; Cardiovascular Diseases - etiology ; Cardiovascular Diseases - prevention & control ; Cinnamates - administration & dosage ; Cinnamates - adverse effects ; Cinnamates - therapeutic use ; clinical trial ; Cohort Studies ; Cyclohexanes - administration & dosage ; Cyclohexanes - adverse effects ; Cyclohexanes - therapeutic use ; Double-Blind Method ; Enzyme Inhibitors - administration & dosage ; Enzyme Inhibitors - adverse effects ; Enzyme Inhibitors - therapeutic use ; Epoxy Compounds - administration & dosage ; Epoxy Compounds - adverse effects ; Epoxy Compounds - therapeutic use ; Evidence-based medicine ; Female ; Follow-Up Studies ; Glycoproteins - antagonists & inhibitors ; Glycoproteins - metabolism ; Humans ; Hypothalamus - injuries ; Injections, Subcutaneous ; Male ; Metabolic Syndrome - epidemiology ; Metabolic Syndrome - etiology ; Metabolic Syndrome - prevention & control ; Obesity ; obesity therapy ; Obesity, Morbid - blood ; Obesity, Morbid - drug therapy ; Obesity, Morbid - etiology ; Obesity, Morbid - physiopathology ; phase I to II study ; Proof of Concept Study ; randomised trial ; Risk ; Sesquiterpenes - administration & dosage ; Sesquiterpenes - adverse effects ; Sesquiterpenes - therapeutic use ; Weight control ; Weight Loss - drug effects ; Young Adult]]></subject><ispartof>Diabetes, obesity & metabolism, 2017-08, Vol.19 (8), p.1165-1170</ispartof><rights>2017 John Wiley & Sons Ltd</rights><rights>2017 John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3888-d170cbabd9b4194bba5b0aa1800bfea8e682701cfac96115c16f687fea10d68f3</citedby><cites>FETCH-LOGICAL-c3888-d170cbabd9b4194bba5b0aa1800bfea8e682701cfac96115c16f687fea10d68f3</cites><orcidid>0000-0003-1628-3677</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.12928$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.12928$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28261955$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shoemaker, Ashley</creatorcontrib><creatorcontrib>Proietto, Joseph</creatorcontrib><creatorcontrib>Abuzzahab, M. Jennifer</creatorcontrib><creatorcontrib>Markovic, Tania</creatorcontrib><creatorcontrib>Malloy, Jaret</creatorcontrib><creatorcontrib>Kim, Dennis D.</creatorcontrib><title>A randomized, placebo‐controlled trial of beloranib for the treatment of hypothalamic injury‐associated obesity</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aims
Hypothalamic injury‐associated obesity (HIAO) results from damage to the hypothalamus that often occurs with surgical removal/radiation therapy of tumours in the hypothalamic region, such as craniopharyngioma. There is currently no rigorously studied pharmaceutical treatment for the intractable weight gain and cardiometabolic consequences that occur in patients with HIAO. We aimed to assess efficacy, safety and tolerability of beloranib treatment for 4 to 8 weeks in patients with HIAO.
Materials and methods
This Phase 2a, double‐blind, placebo‐controlled study included 14 patients with HIAO, randomized to receive beloranib 1.8 mg or placebo subcutaneously twice weekly for 4 weeks with an optional 4‐week open‐label extension in which all patients received beloranib. The primary endpoint was change in weight from baseline to Week 4.
Results
Participants were 64% female, with a mean (SD) age of 32 (9) years, BMI of 43 (7) kg/m2 and weight of 126 (22) kg. Compared with placebo (N = 4), beloranib 1.8 mg (N = 8) resulted in a mean (95% CI) difference in weight of −3.2 (−5.4, −0.9) kg after 4 weeks. Weight loss continued through the 8 weeks in patients randomized to beloranib (mean −6.2 [−8.2, −4.1] kg). Beloranib treatment was associated with improvements in high‐sensitivity CRP. Adverse events were mild to moderate. No patients who received beloranib discontinued treatment.
Conclusion
Beloranib treatment resulted in progressive weight loss in patients with HIAO that was comparable to that observed with beloranib in patients with exogenous obesity. These findings indicate a novel mechanism for treating obesity in patients with HIAO.</description><subject>Adult</subject><subject>Aminopeptidases - antagonists & inhibitors</subject><subject>Aminopeptidases - metabolism</subject><subject>antiobesity drug</subject><subject>appetite control</subject><subject>Appetite Depressants - administration & dosage</subject><subject>Appetite Depressants - adverse effects</subject><subject>Appetite Depressants - therapeutic use</subject><subject>Biomarkers - blood</subject><subject>Body Mass Index</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Cardiovascular Diseases - etiology</subject><subject>Cardiovascular Diseases - prevention & control</subject><subject>Cinnamates - administration & dosage</subject><subject>Cinnamates - adverse effects</subject><subject>Cinnamates - therapeutic use</subject><subject>clinical trial</subject><subject>Cohort Studies</subject><subject>Cyclohexanes - administration & dosage</subject><subject>Cyclohexanes - adverse effects</subject><subject>Cyclohexanes - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Enzyme Inhibitors - administration & dosage</subject><subject>Enzyme Inhibitors - adverse effects</subject><subject>Enzyme Inhibitors - therapeutic use</subject><subject>Epoxy Compounds - administration & dosage</subject><subject>Epoxy Compounds - adverse effects</subject><subject>Epoxy Compounds - therapeutic use</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Glycoproteins - antagonists & inhibitors</subject><subject>Glycoproteins - metabolism</subject><subject>Humans</subject><subject>Hypothalamus - injuries</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Metabolic Syndrome - epidemiology</subject><subject>Metabolic Syndrome - etiology</subject><subject>Metabolic Syndrome - prevention & control</subject><subject>Obesity</subject><subject>obesity therapy</subject><subject>Obesity, Morbid - blood</subject><subject>Obesity, Morbid - drug therapy</subject><subject>Obesity, Morbid - etiology</subject><subject>Obesity, Morbid - physiopathology</subject><subject>phase I to II study</subject><subject>Proof of Concept Study</subject><subject>randomised trial</subject><subject>Risk</subject><subject>Sesquiterpenes - administration & dosage</subject><subject>Sesquiterpenes - adverse effects</subject><subject>Sesquiterpenes - therapeutic use</subject><subject>Weight control</subject><subject>Weight Loss - drug effects</subject><subject>Young Adult</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1q3TAQRkVpadK0i75AMXTTQp1oZFuWliHpHyRk066FJI-5usjWrSQT3FUeoc_YJ6mSm2YRyGxm4DschhlC3gI9hlInQ5iOgUkmnpFDaHlTQ8P487uZ1UJSdkBepbSllLaN6F-SAyYYB9l1hySdVlHPReB-4_Cp2nlt0YS_N39smHMM3uNQ5ei0r8JYGfSh0M5UY4hV3mCJUOcJ53wbb9ZdyBvt9eRs5ebtEtci0ikF63QuomAwuby-Ji9G7RO-ue9H5OeXzz_OvtUXV1-_n51e1LYRQtQD9NQabQZpWpCtMbozVGsQlJoRtUAuWE_BjtpKDtBZ4CMXfYmADlyMzRH5sPfuYvi1YMpqcsmi93rGsCQFom970cqGFvT9I3QbljiX7RRIRnnXtY0s1Mc9ZWNIKeKodtFNOq4KqLr9hCqHVHefKOy7e-NiJhweyP-nL8DJHrh2HtenTer86nKv_AffLJZY</recordid><startdate>201708</startdate><enddate>201708</enddate><creator>Shoemaker, Ashley</creator><creator>Proietto, Joseph</creator><creator>Abuzzahab, M. Jennifer</creator><creator>Markovic, Tania</creator><creator>Malloy, Jaret</creator><creator>Kim, Dennis D.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1628-3677</orcidid></search><sort><creationdate>201708</creationdate><title>A randomized, placebo‐controlled trial of beloranib for the treatment of hypothalamic injury‐associated obesity</title><author>Shoemaker, Ashley ; Proietto, Joseph ; Abuzzahab, M. Jennifer ; Markovic, Tania ; Malloy, Jaret ; Kim, Dennis D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3888-d170cbabd9b4194bba5b0aa1800bfea8e682701cfac96115c16f687fea10d68f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aminopeptidases - antagonists & inhibitors</topic><topic>Aminopeptidases - metabolism</topic><topic>antiobesity drug</topic><topic>appetite control</topic><topic>Appetite Depressants - administration & dosage</topic><topic>Appetite Depressants - adverse effects</topic><topic>Appetite Depressants - therapeutic use</topic><topic>Biomarkers - blood</topic><topic>Body Mass Index</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Cardiovascular Diseases - etiology</topic><topic>Cardiovascular Diseases - prevention & control</topic><topic>Cinnamates - administration & dosage</topic><topic>Cinnamates - adverse effects</topic><topic>Cinnamates - therapeutic use</topic><topic>clinical trial</topic><topic>Cohort Studies</topic><topic>Cyclohexanes - administration & dosage</topic><topic>Cyclohexanes - adverse effects</topic><topic>Cyclohexanes - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Enzyme Inhibitors - administration & dosage</topic><topic>Enzyme Inhibitors - adverse effects</topic><topic>Enzyme Inhibitors - therapeutic use</topic><topic>Epoxy Compounds - administration & dosage</topic><topic>Epoxy Compounds - adverse effects</topic><topic>Epoxy Compounds - therapeutic use</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Glycoproteins - antagonists & inhibitors</topic><topic>Glycoproteins - metabolism</topic><topic>Humans</topic><topic>Hypothalamus - injuries</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Metabolic Syndrome - epidemiology</topic><topic>Metabolic Syndrome - etiology</topic><topic>Metabolic Syndrome - prevention & control</topic><topic>Obesity</topic><topic>obesity therapy</topic><topic>Obesity, Morbid - blood</topic><topic>Obesity, Morbid - drug therapy</topic><topic>Obesity, Morbid - etiology</topic><topic>Obesity, Morbid - physiopathology</topic><topic>phase I to II study</topic><topic>Proof of Concept Study</topic><topic>randomised trial</topic><topic>Risk</topic><topic>Sesquiterpenes - administration & dosage</topic><topic>Sesquiterpenes - adverse effects</topic><topic>Sesquiterpenes - therapeutic use</topic><topic>Weight control</topic><topic>Weight Loss - drug effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shoemaker, Ashley</creatorcontrib><creatorcontrib>Proietto, Joseph</creatorcontrib><creatorcontrib>Abuzzahab, M. Jennifer</creatorcontrib><creatorcontrib>Markovic, Tania</creatorcontrib><creatorcontrib>Malloy, Jaret</creatorcontrib><creatorcontrib>Kim, Dennis D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shoemaker, Ashley</au><au>Proietto, Joseph</au><au>Abuzzahab, M. Jennifer</au><au>Markovic, Tania</au><au>Malloy, Jaret</au><au>Kim, Dennis D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized, placebo‐controlled trial of beloranib for the treatment of hypothalamic injury‐associated obesity</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2017-08</date><risdate>2017</risdate><volume>19</volume><issue>8</issue><spage>1165</spage><epage>1170</epage><pages>1165-1170</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>Aims
Hypothalamic injury‐associated obesity (HIAO) results from damage to the hypothalamus that often occurs with surgical removal/radiation therapy of tumours in the hypothalamic region, such as craniopharyngioma. There is currently no rigorously studied pharmaceutical treatment for the intractable weight gain and cardiometabolic consequences that occur in patients with HIAO. We aimed to assess efficacy, safety and tolerability of beloranib treatment for 4 to 8 weeks in patients with HIAO.
Materials and methods
This Phase 2a, double‐blind, placebo‐controlled study included 14 patients with HIAO, randomized to receive beloranib 1.8 mg or placebo subcutaneously twice weekly for 4 weeks with an optional 4‐week open‐label extension in which all patients received beloranib. The primary endpoint was change in weight from baseline to Week 4.
Results
Participants were 64% female, with a mean (SD) age of 32 (9) years, BMI of 43 (7) kg/m2 and weight of 126 (22) kg. Compared with placebo (N = 4), beloranib 1.8 mg (N = 8) resulted in a mean (95% CI) difference in weight of −3.2 (−5.4, −0.9) kg after 4 weeks. Weight loss continued through the 8 weeks in patients randomized to beloranib (mean −6.2 [−8.2, −4.1] kg). Beloranib treatment was associated with improvements in high‐sensitivity CRP. Adverse events were mild to moderate. No patients who received beloranib discontinued treatment.
Conclusion
Beloranib treatment resulted in progressive weight loss in patients with HIAO that was comparable to that observed with beloranib in patients with exogenous obesity. These findings indicate a novel mechanism for treating obesity in patients with HIAO.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>28261955</pmid><doi>10.1111/dom.12928</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0003-1628-3677</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | Diabetes, obesity & metabolism, 2017-08, Vol.19 (8), p.1165-1170 |
| issn | 1462-8902 1463-1326 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aminopeptidases - antagonists & inhibitors Aminopeptidases - metabolism antiobesity drug appetite control Appetite Depressants - administration & dosage Appetite Depressants - adverse effects Appetite Depressants - therapeutic use Biomarkers - blood Body Mass Index Cardiovascular Diseases - epidemiology Cardiovascular Diseases - etiology Cardiovascular Diseases - prevention & control Cinnamates - administration & dosage Cinnamates - adverse effects Cinnamates - therapeutic use clinical trial Cohort Studies Cyclohexanes - administration & dosage Cyclohexanes - adverse effects Cyclohexanes - therapeutic use Double-Blind Method Enzyme Inhibitors - administration & dosage Enzyme Inhibitors - adverse effects Enzyme Inhibitors - therapeutic use Epoxy Compounds - administration & dosage Epoxy Compounds - adverse effects Epoxy Compounds - therapeutic use Evidence-based medicine Female Follow-Up Studies Glycoproteins - antagonists & inhibitors Glycoproteins - metabolism Humans Hypothalamus - injuries Injections, Subcutaneous Male Metabolic Syndrome - epidemiology Metabolic Syndrome - etiology Metabolic Syndrome - prevention & control Obesity obesity therapy Obesity, Morbid - blood Obesity, Morbid - drug therapy Obesity, Morbid - etiology Obesity, Morbid - physiopathology phase I to II study Proof of Concept Study randomised trial Risk Sesquiterpenes - administration & dosage Sesquiterpenes - adverse effects Sesquiterpenes - therapeutic use Weight control Weight Loss - drug effects Young Adult |
| title | A randomized, placebo‐controlled trial of beloranib for the treatment of hypothalamic injury‐associated obesity |
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