A Retrospective Real-World Cohort Study

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

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. 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)

4. 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)

5. Age distribution

   Measured in years

   Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

6. 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)

7. 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)

8. 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)

9. BMI distribution

   Measured as kilogram (kg)/m^2

   Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

10. 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)

11. 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)

12. 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)

13. 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)

14. 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)

15. 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)

16. Laboratory assessment of ferritin

    Measured in nanogram (ng)/mL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

17. Laboratory assessment of transferrin

    Measured in mg/ deciliter (dL)

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

18. Laboratory assessment of serum creatinine

    Measured in mg/dL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

19. 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)

20. 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)

21. 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)

22. 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)

23. 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)

24. 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)

25. 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)

26. 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)

27. 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)

28. 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)

29. 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)

30. Laboratory assessment of fasting glucose

    Measured in mg/dL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

31. Laboratory assessment of hemoglobin (Hb)

    Measured in g/dL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

32. 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)

33. Laboratory assessment of triglycerides

    Measured in mg/dL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

34. Laboratory assessment of total cholesterol

    Measured in mg/dL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

35. 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)

36. 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)

37. 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)

38. 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)

39. 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)

40. 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)

41. 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)

42. 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)

43. 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)

44. 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)

45. Laboratory assessment of progesterone levels

    Measured in ng/mL

    Measured: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

46. 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)

47. 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.

1. First posted24 Aug 2026
2. Study start20 Aug 2026
3. Primary completion2 Nov 2026 (estimated)
4. 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.