Metabolic DiseaseSemaglutideNCT07043361
Efficacy of Semaglutide in Glycemic Control, Weight Loss, and Improving Lipidogram- Role of Baseline Vitamin D Levels
An observational study of Metabolic Disease, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Objective: Semaglutide, a glucagon-like peptide-1 receptor agonist, is an established therapy for type 2 diabetes (T2D), offering robust glycemic control and weight reduction. Vitamin D has been implicated in metabolic regulation, yet its influence on semaglutide-induced outcomes remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- semaglutide
- How many people
- 5,300 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Dec 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetic patients on semaglutide treatment and with available baseline vitamin D levels
Who may be able to join
- Diabetes type II treated with semaglutide
- Available baseline vitamin D levels
Who cannot join
- Missing serum 25-hydroxyvitamin D (25[OH]D) data
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Semaglutide in Glycemic Control, Weight Loss, and Improving Lipid Profile- the Role of Baseline Vitamin D Levels
Objective: Semaglutide, a glucagon-like peptide-1 receptor agonist, is an established therapy for type 2 diabetes (T2D), offering robust glycemic control and weight reduction. Vitamin D has been implicated in metabolic regulation, yet its influence on semaglutide-induced outcomes remains unclear.
Research Design and Methods: the investigators conducted a cross-sectional analysis of 5,300 adults with T2D, enrolled in Leumit Health Services, who initiated semaglutide therapy between February 1, 2019, and December 31, 2022. All patients had documented serum 25-hydroxyvitamin D [25(OH)D] levels prior to treatment initiation. Metabolic outcomes- including glycemic control (HbA1c), body mass index (BMI), and lipid profile- were assessed at 12 months. Associations between baseline 25(OH)D levels and metabolic changes were evaluated using multivariable regression models, adjusted for demographic and clinical covariates.
Read the detailed description
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, was initially approved for the treatment of type 2 diabetes mellitus (T2DM) due to its superior glucose-lowering efficacy compared to oral antidiabetic agents, with a favorable safety profile regarding hypoglycemia risk. In June 2021, the U.S. Food and Drug Administration (FDA) approved higher doses of semaglutide for long-term weight management, marking the first pharmacologic advancement in obesity treatment since 2014 (FDA, 2021).
Semaglutide exerts its effects through multiple mechanisms, including delayed gastric emptying, appetite suppression, enhanced glucose-stimulated insulin secretion from pancreatic β-cells, and reduced glucagon secretion. In individuals with overweight and obese, semaglutide induces substantial and sustained weight reduction, with an average decrease of approximately 14.9% of baseline body weight.
The pathophysiology of T2DM varies across racial and ethnic groups. For example, T2DM in Caucasian populations is primarily characterized by obesity and insulin resistance, whereas in East Asians, including the Japanese, early-onset β-cell dysfunction and insulin deficiency predominate. Consequently, the glycemic response to semaglutide is not uniform across populations. Notably, semaglutide predominantly enhances first-phase insulin secretion, an effect that may be particularly beneficial in individuals with insulin deficiency. Several blinded, controlled trials have demonstrated superior glycemic control with semaglutide in Asian populations, reinforcing the significance of insulin resistance versus insulin deficiency in determining its net metabolic effects.
While genetic and ethnic determinants of semaglutide response are largely non-modifiable, certain adjunctive interventions may optimize its therapeutic effects. Among these, vitamin D has emerged as a potential modulator of molecular pathways involved in metabolic regulation. In regard to diabetes control, vitamin D is a key immunomodulatory factor, and preclinical studies have demonstrated its protective effects against β-cell dysfunction in diabetes. In murine models, early vitamin D administration mitigated the inflammatory insults responsible for β-cell destruction, thereby preventing autoimmune diabetes onset. These findings are supported by human studies in prediabetic and newly diagnosed T2DM individuals, in whom long-term vitamin D supplementation (six months) significantly improved peripheral insulin sensitivity and β-cell function, potentially delaying diabetes progression.
Obesity has long been linked to vitamin D deficiency. While the role of vitamin D in weight loss remains debated, a recent meta-analysis highlighted its potential clinical efficacy in optimizing weight reduction. Specifically, three months of vitamin D supplementation in obese women significantly augmented weight loss and improved metabolic parameters.
Given the high prevalence of vitamin D deficiency, particularly among individuals with obesity and T2DM, supplementation may offer metabolic benefits.
To date, the relationship between vitamin D status and the metabolic effects of semaglutide has not been well characterized. In this retrospective cross-sectional study, The investigators aimed to investigate the association between baseline vitamin D levels and semaglutide-induced glycemic control and weight loss in an Israeli T2DM population.
- Conditions
- Metabolic Disease
- Being tested
- semaglutide
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
testing the effect of baseline vitamin D on metabolic effects of semaglutide
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients on semaglutide | we tested the relation between baseline vitamin D levels and metabolic amplification of semaglutide metabolic effects Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative weight loss measured by BMI
testing semaglutide induced weight loss as a function of baseline vitamin D levels
Measured: 12 months from semaglutide initiation
glycemic control using Hgb1C
testing semaglutide induced glycemic control as a function of baseline vitamin D levels
Measured: 12 months from semaglutide initiation
lipid control using LDL and TG
testing semaglutide induced lipid control as a function of baseline vitamin D levels
Measured: 12 months from semaglutide initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start18 Dec 2023
- Primary completion21 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 5,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- rami abo fanne, MD PhD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043361
- Sponsor's protocol ID
- 0034-23-LEU
- Other IDs
- Non applicable
- Acronym
- Semaglutide
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: data is personal and secured
Publications
Miles KE, Kerr JL. Semaglutide for the Treatment of Type 2 Diabetes Mellitus. J Pharm Technol. 2018 Dec;34(6):281-289. doi: 10.1177/8755122518790925. Epub 2018 Jul 30.
PubMed 34861016Andersen A, Knop FK, Vilsboll T. A Pharmacological and Clinical Overview of Oral Semaglutide for the Treatment of Type 2 Diabetes. Drugs. 2021 Jun;81(9):1003-1030. doi: 10.1007/s40265-021-01499-w. Epub 2021 May 8.
PubMed 33964002Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
PubMed 36151309Evans M, Morgan AR, Bain SC, Davies S, Hicks D, Brown P, Yousef Z, Dashora U, Viljoen A, Beba H, Strain WD. Meeting the Challenge of Virtual Diabetes Care: A Consensus Viewpoint on the Positioning and Value of Oral Semaglutide in Routine Clinical Practice. Diabetes Ther. 2022 Feb;13(2):225-240. doi: 10.1007/s13300-021-01201-z. Epub 2022 Jan 19.
PubMed 35044569Kalra S, Kapoor N. Oral Semaglutide: Dosage in Special Situations. Diabetes Ther. 2022 Jun;13(6):1133-1137. doi: 10.1007/s13300-022-01265-5. Epub 2022 May 7.
PubMed 35532859Wilding 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. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
PubMed 33567185Seino Y, Kuwata H, Yabe D. Incretin-based drugs for type 2 diabetes: Focus on East Asian perspectives. J Diabetes Investig. 2016 Apr;7 Suppl 1(Suppl 1):102-9. doi: 10.1111/jdi.12490. Epub 2016 Apr 18.
PubMed 27186364Yabe D, Seino Y, Fukushima M, Seino S. beta cell dysfunction versus insulin resistance in the pathogenesis of type 2 diabetes in East Asians. Curr Diab Rep. 2015 Jun;15(6):602. doi: 10.1007/s11892-015-0602-9.
PubMed 25944304Kakei M, Yoshida M, Dezaki K, Ito K, Yamada H, Funazaki S, Kawakami M, Sugawara H, Yada T. Glucose and GTP-binding protein-coupled receptor cooperatively regulate transient receptor potential-channels to stimulate insulin secretion [Review]. Endocr J. 2016 Oct 29;63(10):867-876. doi: 10.1507/endocrj.EJ16-0262. Epub 2016 Jul 17.
PubMed 27321586Yosida M, Dezaki K, Uchida K, Kodera S, Lam NV, Ito K, Rita RS, Yamada H, Shimomura K, Ishikawa SE, Sugawara H, Kawakami M, Tominaga M, Yada T, Kakei M. Involvement of cAMP/EPAC/TRPM2 activation in glucose- and incretin-induced insulin secretion. Diabetes. 2014 Oct;63(10):3394-403. doi: 10.2337/db13-1868. Epub 2014 May 13.
PubMed 24824430Yabe D, Yamada Y, Kaku K, Nishida T, Sato T, Seino Y. Efficacy and safety of once-weekly semaglutide in Japanese individuals with type 2 diabetes by baseline age and body mass index. J Diabetes Investig. 2022 Jul;13(7):1161-1174. doi: 10.1111/jdi.13773. Epub 2022 Mar 9.
PubMed 35174649Kim YG, Hahn S, Oh TJ, Park KS, Cho YM. Differences in the HbA1c-lowering efficacy of glucagon-like peptide-1 analogues between Asians and non-Asians: a systematic review and meta-analysis. Diabetes Obes Metab. 2014 Oct;16(10):900-9. doi: 10.1111/dom.12293. Epub 2014 Apr 15.
PubMed 24655583Kang YM, Cho YK, Lee J, Lee SE, Lee WJ, Park JY, Kim YJ, Jung CH, Nauck MA. Asian Subpopulations May Exhibit Greater Cardiovascular Benefit from Long-Acting Glucagon-Like Peptide 1 Receptor Agonists: A Meta-Analysis of Cardiovascular Outcome Trials. Diabetes Metab J. 2019 Aug;43(4):410-421. doi: 10.4093/dmj.2018.0070. Epub 2018 Dec 27.
PubMed 30604598Gysemans CA, Cardozo AK, Callewaert H, Giulietti A, Hulshagen L, Bouillon R, Eizirik DL, Mathieu C. 1,25-Dihydroxyvitamin D3 modulates expression of chemokines and cytokines in pancreatic islets: implications for prevention of diabetes in nonobese diabetic mice. Endocrinology. 2005 Apr;146(4):1956-64. doi: 10.1210/en.2004-1322. Epub 2005 Jan 6.
PubMed 15637289Lemieux P, Weisnagel SJ, Caron AZ, Julien AS, Morisset AS, Carreau AM, Poirier J, Tchernof A, Robitaille J, Bergeron J, Marette A, Vohl MC, Gagnon C. Effects of 6-month vitamin D supplementation on insulin sensitivity and secretion: a randomised, placebo-controlled trial. Eur J Endocrinol. 2019 Sep;181(3):287-299. doi: 10.1530/EJE-19-0156.
PubMed 31344685
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Semaglutide in Glycemic Control, Weight Loss, and Improving Lipid Profile- the Role of Baseline Vitamin D Levels
- ClinicalTrials.gov ID
- NCT07043361
- Acronym / sponsor ID
- Semaglutide / 0034-23-LEU
- Conditions
- Metabolic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,300 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: Semaglutide, a glucagon-like peptide-1 receptor agonist, is an established therapy for type 2 diabetes (T2D), offering robust glycemic control and weight reduction. Vitamin D has been implicated in metabolic regulation, yet its influence on semaglutide-induced outcomes remains unclear.
Research Design and Methods: the investigators conducted a cross-sectional analysis of 5,300 adults with T2D, enrolled in Leumit Health Services, who initiated semaglutide therapy between February 1, 2019, and December 31, 2022. All patients had documented serum 25-hydroxyvitamin D [25(OH)D] levels prior to treatment initiation. Metabolic outcomes- including glycemic control (HbA1c), body mass index (BMI), and lipid profile- were assessed at 12 months. Associations between baseline 25(OH)D levels and metabolic changes were evaluated using multivariable regression models, adjusted for demographic and clinical covariates.
Detailed description
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, was initially approved for the treatment of type 2 diabetes mellitus (T2DM) due to its superior glucose-lowering efficacy compared to oral antidiabetic agents, with a favorable safety profile regarding hypoglycemia risk. In June 2021, the U.S. Food and Drug Administration (FDA) approved higher doses of semaglutide for long-term weight management, marking the first pharmacologic advancement in obesity treatment since 2014 (FDA, 2021).
Semaglutide exerts its effects through multiple mechanisms, including delayed gastric emptying, appetite suppression, enhanced glucose-stimulated insulin secretion from pancreatic β-cells, and reduced glucagon secretion. In individuals with overweight and obese, semaglutide induces substantial and sustained weight reduction, with an average decrease of approximately 14.9% of baseline body weight.
The pathophysiology of T2DM varies across racial and ethnic groups. For example, T2DM in Caucasian populations is primarily characterized by obesity and insulin resistance, whereas in East Asians, including the Japanese, early-onset β-cell dysfunction and insulin deficiency predominate. Consequently, the glycemic response to semaglutide is not uniform across populations. Notably, semaglutide predominantly enhances first-phase insulin secretion, an effect that may be particularly beneficial in individuals with insulin deficiency. Several blinded, controlled trials have demonstrated superior glycemic control with semaglutide in Asian populations, reinforcing the significance of insulin resistance versus insulin deficiency in determining its net metabolic effects.
While genetic and ethnic determinants of semaglutide response are largely non-modifiable, certain adjunctive interventions may optimize its therapeutic effects. Among these, vitamin D has emerged as a potential modulator of molecular pathways involved in metabolic regulation. In regard to diabetes control, vitamin D is a key immunomodulatory factor, and preclinical studies have demonstrated its protective effects against β-cell dysfunction in diabetes. In murine models, early vitamin D administration mitigated the inflammatory insults responsible for β-cell destruction, thereby preventing autoimmune diabetes onset. These findings are supported by human studies in prediabetic and newly diagnosed T2DM individuals, in whom long-term vitamin D supplementation (six months) significantly improved peripheral insulin sensitivity and β-cell function, potentially delaying diabetes progression.
Obesity has long been linked to vitamin D deficiency. While the role of vitamin D in weight loss remains debated, a recent meta-analysis highlighted its potential clinical efficacy in optimizing weight reduction. Specifically, three months of vitamin D supplementation in obese women significantly augmented weight loss and improved metabolic parameters.
Given the high prevalence of vitamin D deficiency, particularly among individuals with obesity and T2DM, supplementation may offer metabolic benefits.
To date, the relationship between vitamin D status and the metabolic effects of semaglutide has not been well characterized. In this retrospective cross-sectional study, The investigators aimed to investigate the association between baseline vitamin D levels and semaglutide-induced glycemic control and weight loss in an Israeli T2DM population.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic patients on semaglutide | – | Drug: semaglutidewe tested the relation between baseline vitamin D levels and metabolic amplification of semaglutide metabolic effects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients on semaglutide treatment and with available baseline vitamin D levels
Key inclusion criteria (2 listed)
- Diabetes type II treated with semaglutide
- Available baseline vitamin D levels
Key exclusion criteria (2 listed)
- Missing serum 25-hydroxyvitamin D (25[OH]D) data
- Pregnant or lactating females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutidetesting the effect of baseline vitamin D on metabolic effects of semaglutide | Drug | diabetic patients on semaglutide |
Primary outcome
relative weight loss measured by BMI
Time frame: 12 months from semaglutide initiation
testing semaglutide induced weight loss as a function of baseline vitamin D levels
glycemic control using Hgb1C
Time frame: 12 months from semaglutide initiation
testing semaglutide induced glycemic control as a function of baseline vitamin D levels
lipid control using LDL and TG
Time frame: 12 months from semaglutide initiation
testing semaglutide induced lipid control as a function of baseline vitamin D levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 34861016Miles KE, Kerr JL. Semaglutide for the Treatment of Type 2 Diabetes Mellitus. J Pharm Technol. 2018 Dec;34(6):281-289. doi: 10.1177/8755122518790925. Epub 2018 Jul 30.
- Background: PubMed 33964002Andersen A, Knop FK, Vilsboll T. A Pharmacological and Clinical Overview of Oral Semaglutide for the Treatment of Type 2 Diabetes. Drugs. 2021 Jun;81(9):1003-1030. doi: 10.1007/s40265-021-01499-w. Epub 2021 May 8.
- Background: PubMed 36151309Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
- Background: PubMed 35044569Evans M, Morgan AR, Bain SC, Davies S, Hicks D, Brown P, Yousef Z, Dashora U, Viljoen A, Beba H, Strain WD. Meeting the Challenge of Virtual Diabetes Care: A Consensus Viewpoint on the Positioning and Value of Oral Semaglutide in Routine Clinical Practice. Diabetes Ther. 2022 Feb;13(2):225-240. doi: 10.1007/s13300-021-01201-z. Epub 2022 Jan 19.
- Background: PubMed 35532859Kalra S, Kapoor N. Oral Semaglutide: Dosage in Special Situations. Diabetes Ther. 2022 Jun;13(6):1133-1137. doi: 10.1007/s13300-022-01265-5. Epub 2022 May 7.
- Background: PubMed 33567185Wilding 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. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
- Background: PubMed 27186364Seino Y, Kuwata H, Yabe D. Incretin-based drugs for type 2 diabetes: Focus on East Asian perspectives. J Diabetes Investig. 2016 Apr;7 Suppl 1(Suppl 1):102-9. doi: 10.1111/jdi.12490. Epub 2016 Apr 18.
- Background: PubMed 25944304Yabe D, Seino Y, Fukushima M, Seino S. beta cell dysfunction versus insulin resistance in the pathogenesis of type 2 diabetes in East Asians. Curr Diab Rep. 2015 Jun;15(6):602. doi: 10.1007/s11892-015-0602-9.
- Background: PubMed 27321586Kakei M, Yoshida M, Dezaki K, Ito K, Yamada H, Funazaki S, Kawakami M, Sugawara H, Yada T. Glucose and GTP-binding protein-coupled receptor cooperatively regulate transient receptor potential-channels to stimulate insulin secretion [Review]. Endocr J. 2016 Oct 29;63(10):867-876. doi: 10.1507/endocrj.EJ16-0262. Epub 2016 Jul 17.
- Background: PubMed 24824430Yosida M, Dezaki K, Uchida K, Kodera S, Lam NV, Ito K, Rita RS, Yamada H, Shimomura K, Ishikawa SE, Sugawara H, Kawakami M, Tominaga M, Yada T, Kakei M. Involvement of cAMP/EPAC/TRPM2 activation in glucose- and incretin-induced insulin secretion. Diabetes. 2014 Oct;63(10):3394-403. doi: 10.2337/db13-1868. Epub 2014 May 13.
- Background: PubMed 35174649Yabe D, Yamada Y, Kaku K, Nishida T, Sato T, Seino Y. Efficacy and safety of once-weekly semaglutide in Japanese individuals with type 2 diabetes by baseline age and body mass index. J Diabetes Investig. 2022 Jul;13(7):1161-1174. doi: 10.1111/jdi.13773. Epub 2022 Mar 9.
- Background: PubMed 24655583Kim YG, Hahn S, Oh TJ, Park KS, Cho YM. Differences in the HbA1c-lowering efficacy of glucagon-like peptide-1 analogues between Asians and non-Asians: a systematic review and meta-analysis. Diabetes Obes Metab. 2014 Oct;16(10):900-9. doi: 10.1111/dom.12293. Epub 2014 Apr 15.
- Individual participant dataSharing planned: No. data is personal and secured
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rami abo fanne, MD PhD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative weight loss measured by BMI (time frame: 12 months from semaglutide initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07043361, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.