ObesitySCALA-TK-CMNCT07781371
A Retrospective Real-World Cohort Study
An observational study of Obesity and Type 2 Diabetes (T2D), run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Obesity, Type 2 Diabetes (T2D), Prediabetes
- What is being tested?
- No treatment given
- How many people
- 100,000 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2026to 2 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: SCALA cohort
Who may be able to join
- Participants aged above or equal to 12 years at index date.
- Participants with international classification of diseases (ICD-10) coded diagnosis or secondary criteria for either diabetes (type 2 diabetes, pre-diabetes), overweight, obesity, metabolic dysfunction-associated steatotic liver disease (or non-alcoholic fatty liver disease), cardiovascular disease (arterial hypertension, ischemic heart disease, myocardial infarction, heart failure, cerebrovascular disease (including stroke and transient ischemic attack), atherosclerosis, atrial fibrillation), chronic kidney disease, dyslipidemia.
- At least one healthcare encounter within 12 months prior to index date (pre-index) to ensure availability of baseline data.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCALA-TK-CM: Semaglutide and CArdiometabolic Real-Life Atlas - TürKiye CardioMetabolic Epidemiology Study: A Retrospective Real-World Cohort Study
The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions.
Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.
- Conditions
- Obesity, Type 2 Diabetes (T2D), Prediabetes, Cardiovascular Disease (CVD), Dyslipidemia, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
- Being tested
- No treatment given
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Prediabetic State, Cardiovascular Diseases, Dyslipidemias, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| SCALA cohort | Participants from Acibadem hospital network in Türkiye with index date followed by at least one year of follow-up and the data extraction period spanning from 1 January 2022 to 31 December 2025. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Measured in percentage
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no)
Measured as binary (yes/no)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
Overlap of major cardiometabolic diseases (percentage)
Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as percentage
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Overlap of major cardiometabolic diseases: binary (yes/no)
Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as binary (yes/no)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Age distribution
Measured in years
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Age distribution: Number of participants
Measured as number of participants
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Gender distribution
Defined as male or female. Measured in percentage
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Gender distribution: binary (yes/no)
Defined as count of male or female. Measured as binary (male/female)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
BMI distribution
Measured as kilogram (kg)/m^2
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
BMI distribution: number of participants
Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m^2 )
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Medical history of interest: percentage of events
Measured in percentage of events
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Smoking status: percentage of participants
Defined by the next categories at index date non-smoker, formal smoker, occasional smoker or current smoker. Measured in percentage of participants
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Systolic and diastolic blood pressure (BP)
Measured in millimeters of mercury (mmHg)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP
Measured in milligram (mg) /Liter (L)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L)
Laboratory assessment of CRP . Measured as binary (under and above 2 mg/L)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of ferritin
Measured in nanogram (ng)/mL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of transferrin
Measured in mg/ deciliter (dL)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of serum creatinine
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of estimated glomerular filtration rate (eGFR)
Measured in mL/min/1.73m^2 in categories (under 30 / 30-44 / 45-59 / above or equal to 60 mL/min/1.73m^2)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of creatinine clearance (CrCl)
Measured in mL/ minute (min)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of serum albumin levels
Measured in grams (g)/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of albuminuria
Defined as UACR (urine albumin-to-creatinine ratio) under 30 (A1), above or equal to 30 (A2), or above or equal to 300 mg/g (A3). Measured in mg/g in categories (A1 / A2 / A3)
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of albumin-to-creatinine ratio (ACR)
Measured in mg/g
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of platelets
Measured in 10^9 cells/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of neutrophils
Measured in 10^9 cells/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of lymphocytes
Measured in 10^9 cells/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of monocytes
Measured in 10^9 cells/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT
Measured in ng/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI
Measured in ng/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of fasting glucose
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of hemoglobin (Hb)
Measured in g/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of hemoglobin A1c (HbA1c)
Measured in percentage of total Hb
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of triglycerides
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of total cholesterol
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of lipoprotein A (LpA)
Measured in mg/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of alanine transaminase (ALT)
Measured in unit (U) /L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of aspartate transaminase (AST)
Measured in U/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of FIB-4 score
FIB-4 liver fibrosis score, with previously validated cut-off points to rule in and out the risk of advanced liver fibrosis. FIB-4 score indicating low to high risk ranges from 0.1 (low risk) to 20 (highest risk), where the higher score indicates a higher risk or greater severity of advanced liver fibrosis. Measured categorically as score on the scale (under 1.45, 1.45-2.67, and above 2.67).
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels
Measured in ng/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of thyroid-stimulating hormone (TSH) levels
Measured in milli-unit (mU)/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of follicle-stimulating hormone (FSH) levels
Measured in U/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of luteinizing hormone (LH) levels
Measured in U/L
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of progesterone levels
Measured in ng/mL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of estrogen levels
Measured in picograms (pg)/mL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of testosterone levels
Measured in ng/dL
Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start20 Aug 2026
- Primary completion2 Nov 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781371
- Sponsor's protocol ID
- DAS-9012
- Other IDs
- U1111-1341-4025
- Acronym
- SCALA-TK-CM
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCALA-TK-CM: Semaglutide and CArdiometabolic Real-Life Atlas - TürKiye CardioMetabolic Epidemiology Study: A Retrospective Real-World Cohort Study
- ClinicalTrials.gov ID
- NCT07781371
- Acronym / sponsor ID
- SCALA-TK-CM / DAS-9012
- Conditions
- Obesity, Type 2 Diabetes (T2D), Prediabetes, Cardiovascular Disease (CVD), Dyslipidemia, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 24 Aug 2026 (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.
The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions.
Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCALA cohort | – | Other: No treatment givenParticipants from Acibadem hospital network in Türkiye with index date followed by at least one year of follow-up and the data extraction period spanning from 1 January 2022 to 31 December 2025. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SCALA cohort
Key inclusion criteria (3 listed)
- Participants aged above or equal to 12 years at index date.
- Participants with international classification of diseases (ICD-10) coded diagnosis or secondary criteria for either diabetes (type 2 diabetes, pre-diabetes), overweight, obesity, metabolic dysfunction-associated steatotic liver disease (or non-alcoholic fatty liver disease), cardiovascular disease (arterial hypertension, ischemic heart disease, myocardial infarction, heart failure, cerebrovascular disease (including stroke and transient ischemic attack), atherosclerosis, atrial fibrillation), chronic kidney disease, dyslipidemia.
- At least one healthcare encounter within 12 months prior to index date (pre-index) to ensure availability of baseline data.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| No treatment givenNo treatment given | Other | SCALA cohort |
Primary outcome
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
Measured in percentage
Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
Measured as binary (yes/no)
Overlap of major cardiometabolic diseases (percentage)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as percentage
Overlap of major cardiometabolic diseases: binary (yes/no)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as binary (yes/no)
Age distribution
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in years
Age distribution: Number of participants
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured as number of participants
Gender distribution
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Defined as male or female. Measured in percentage
Gender distribution: binary (yes/no)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Defined as count of male or female. Measured as binary (male/female)
BMI distribution
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured as kilogram (kg)/m^2
BMI distribution: number of participants
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m^2 )
Medical history of interest: percentage of events
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in percentage of events
Smoking status: percentage of participants
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Defined by the next categories at index date non-smoker, formal smoker, occasional smoker or current smoker. Measured in percentage of participants
Systolic and diastolic blood pressure (BP)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in millimeters of mercury (mmHg)
Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in milligram (mg) /Liter (L)
Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of CRP . Measured as binary (under and above 2 mg/L)
Laboratory assessment of ferritin
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in nanogram (ng)/mL
Laboratory assessment of transferrin
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/ deciliter (dL)
Laboratory assessment of serum creatinine
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of estimated glomerular filtration rate (eGFR)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mL/min/1.73m^2 in categories (under 30 / 30-44 / 45-59 / above or equal to 60 mL/min/1.73m^2)
Laboratory assessment of creatinine clearance (CrCl)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mL/ minute (min)
Laboratory assessment of serum albumin levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in grams (g)/dL
Laboratory assessment of albuminuria
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Defined as UACR (urine albumin-to-creatinine ratio) under 30 (A1), above or equal to 30 (A2), or above or equal to 300 mg/g (A3). Measured in mg/g in categories (A1 / A2 / A3)
Laboratory assessment of albumin-to-creatinine ratio (ACR)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/g
Laboratory assessment of platelets
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Laboratory assessment of neutrophils
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Laboratory assessment of lymphocytes
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Laboratory assessment of monocytes
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/L
Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/L
Laboratory assessment of fasting glucose
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of hemoglobin (Hb)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in g/dL
Laboratory assessment of hemoglobin A1c (HbA1c)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in percentage of total Hb
Laboratory assessment of triglycerides
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of total cholesterol
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of lipoprotein A (LpA)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Laboratory assessment of alanine transaminase (ALT)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in unit (U) /L
Laboratory assessment of aspartate transaminase (AST)
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in U/L
Laboratory assessment of FIB-4 score
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
FIB-4 liver fibrosis score, with previously validated cut-off points to rule in and out the risk of advanced liver fibrosis. FIB-4 score indicating low to high risk ranges from 0.1 (low risk) to 20 (highest risk), where the higher score indicates a higher risk or greater severity of advanced liver fibrosis. Measured categorically as score on the scale (under 1.45, 1.45-2.67, and above 2.67).
Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/L
Laboratory assessment of thyroid-stimulating hormone (TSH) levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in milli-unit (mU)/L
Laboratory assessment of follicle-stimulating hormone (FSH) levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in U/L
Laboratory assessment of luteinizing hormone (LH) levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in U/L
Laboratory assessment of progesterone levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/mL
Laboratory assessment of estrogen levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in picograms (pg)/mL
Laboratory assessment of testosterone levels
Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/dL
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Obesity
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
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 Obesity and Type 2 Diabetes (T2D), run by Novo Nordisk A/S at 1 site in Denmark.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Index and yearly prevalence of major cardiometabolic diseases (percentage) (time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year). The study lists 47 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.