Semaglutide

Clinical trials are studying Semaglutide in many different health conditions, from type 2 diabetes and obesity to kidney disease, heart disease, and other disorders. These studies look at how well it works, how safe it is in different groups, and which patients may benefit most. Some trials compare it with placebo, standard care, or other medicines.

Table of Contents

Clinical trials overview

These studies investigate Semaglutide in many different settings, often as an add-on to standard care or compared with placebo.[1][2] The trial data include studies in chronic kidney disease, type 2 diabetes, obesity, heart and blood vessel disease, stroke, infertility, liver disease, and several other conditions.[1][3]

Many trials are designed to see whether Semaglutide improves a main outcome such as blood sugar, body weight, kidney markers, or disease-specific measures.[2][4] Several studies also look at safety, tolerability, and whether treatment works better than placebo or another active treatment.[5]

Conditions being studied

Type 2 diabetes is the most common condition in the dataset, and it appears in many adult and pediatric studies.[2][6] These trials often measure HbA1c, which is a blood test showing average blood sugar over time.[6]

Obesity is another major research area, including studies in adults, adolescents, children, and people with obesity plus other health problems such as atrial fibrillation, resistant hypertension, heart failure, HIV, or sleep apnea.[7][8] Several obesity trials measure body weight, BMI, or percent weight loss as the main result.[7]

Chronic kidney disease is studied in more than one trial, including studies that measure urine albumin-to-creatinine ratio, also called UACR, and estimated kidney function decline.[1][9] Some kidney studies include people with type 2 diabetes, obesity, or both, while others include chronic kidney disease more broadly.[1][9]

There are also trials in cardiovascular disease, coronary artery disease, stroke, glaucoma, Alzheimer’s disease, alcohol use disorder, cannabis use disorder, and diabetic foot ulcer.[3][10] This shows that Semaglutide is being studied far beyond weight and glucose control in the trial program.[3]

Who can take part

The target populations vary widely across studies.[2] Some trials include adults with type 2 diabetes, while others focus on children, teenagers, or young adults with obesity.[6][7]

Several studies include people with extra health risks, such as overweight or obesity plus heart disease, prediabetes, kidney disease, or treatment with antipsychotic medicines.[8][11] Some trials also have very specific groups, such as people with schizophrenia taking clozapine or olanzapine, women with prior gestational diabetes, or patients after kidney transplant.[11][12]

A few studies are in children or adolescents with obesity, including those with hypothalamic obesity secondary to craniopharyngioma or obesity linked to antipsychotic treatment.[7][13] Other studies focus on adults with conditions such as atrial fibrillation, resistant hypertension, or diabetic neuropathy.[8][8]

Trial phases and study design

Most of the Semaglutide trials in the data are Phase 2 or Phase 3 studies.[2] Phase 2 trials usually explore whether the treatment may work and continue to watch for safety, while Phase 3 trials are larger and are used to confirm benefit more strongly.[2]

There are also some Phase 1 studies, such as the oral Semaglutide and dapagliflozin combination study in healthy participants.[4] In that setting, the main goal is to understand how the medicines behave in the body when given together.[4]

A few studies are listed as low intervention, which means the research uses limited extra intervention beyond routine care or simple study procedures.[5] Several trials are randomized, placebo-controlled, or open-label, depending on the question being asked.[5]

Main endpoints being measured

The most common endpoint in the trial data is change in HbA1c, especially in type 2 diabetes studies.[6] This endpoint is used to see whether blood sugar control improves over time.[6]

Weight-related studies often measure change in body weight, BMI, or percent total weight loss.[7][13] Some studies also use thresholds such as achieving at least 5% weight loss or maintaining BMI below an obesity threshold.[7][13]

Kidney studies often use UACR or chronic eGFR slope, which is the rate of long-term kidney function change.[1][9] Heart and blood vessel studies may measure major adverse cardiovascular events, blood pressure, rhythm outcomes, or plaque changes on heart imaging.[8][10]

Some trials use more specialized endpoints, such as modified Rankin Scale after stroke, good quality blastocysts in IVF, wound closure in diabetic foot ulcer, or gene expression in Alzheimer’s disease.[8][5] These endpoints show that the studies are asking very different clinical questions, not only weight or glucose questions.[5]

Special and less common research areas

Several trials explore Semaglutide in areas that are not the usual diabetes or obesity setting.[10] For example, some studies look at diabetic retinopathy, glaucoma, multiple sclerosis, depression, alcohol use disorder, cannabis use disorder, and chemsex-related drug craving.[10][14]

Other studies focus on inflammation, endothelial biomarkers, bone turnover, platelet reactivity, liver fat, or hepatic fibrosis.[3][9][15] These are all biological signs that may help explain whether the treatment changes disease activity, not just symptoms.[15]

Some trial titles also mention combination approaches, such as CagriSema, IcoSema, or Semaglutide with other medicines like finerenone or dapagliflozin.[1][4] In these studies, Semaglutide is being tested as part of a broader treatment strategy rather than alone.[1]

What these trials may help answer

Together, the studies ask where Semaglutide may help most, which patient groups may benefit, and which outcomes improve first.[2] They also compare different doses, different formulations, and different combinations with other treatments.[4][7]

The data show that research on Semaglutide is broad and still ongoing, with many authorised trials and several completed studies already available.[2] The overall focus is on real clinical results that matter to patients, such as blood sugar, weight, kidney health, heart outcomes, and quality of life.[6][8]

Trial ID Phase Condition studied Status Enrollment
2025-522503-18-00 Phase 3 Chronic kidney disease Authorised 160
2025-520802-37-00 Phase 3 Type 2 diabetes mellitus Authorised 80
2025-522970-35-00 Low Intervention Coronary artery disease, prediabetes Authorised 158
2022-500007-52-00 Phase 1 Type 2 diabetes Completed 138
2025-522525-34-00 Phase 3 Infertility Authorised 62
2022-502679-43-00 Phase 3 Type 2 diabetes Completed 274
2022-500143-21-01 Phase 3 Type 2 diabetes Authorised 7300
2022-501072-25-02 Phase 2 Ischemic stroke Authorised 380
NCT06184633 Phase 3 Obesity, atrial fibrillation Authorised 280
NCT05569772 Low Intervention Prediabetes Authorised 252
2022-502139-20-00 Phase 2 Mucositis and systemical inflammation after high-dose chemotherapy Authorised 40
2023-504913-65-01 Phase 2 Type 2 diabetes, diabetic foot ulcer Authorised 100
2023-506827-26-00 Phase 3 Type 2 diabetes, diabetic retinopathy Authorised 1467
NCT04777409 Phase 3 Mild cognitive impairment or mild dementia of the Alzheimer’s type Completed 1953
2023-506923-27-00 Phase 3 Type 2 diabetes in children and adolescents Completed 132

Ongoing Clinical Trials on Semaglutide

  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary Poland Portugal +1
  • Study of dapagliflozin and semaglutide to reverse prediabetes to normal blood sugar levels in patients with coronary artery disease

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark
  • Study of Semaglutide on Embryo Quality in Overweight and Obese Women Undergoing In Vitro Fertilization for Infertility

    Recruiting

    1 1 1 1
    Investigated diseases:
    Spain
  • A study to evaluate the effectiveness of NNC0662-0419 and semaglutide in people with type 2 diabetes

    Recruiting

    1 1
    Investigated drugs:
    Croatia Hungary Poland Portugal Slovakia Spain
  • Study of semaglutide to reduce cannabis use in adults with cannabis use disorder

    Recruiting

    1 1
    Investigated diseases:
    Denmark
  • Study comparing cagrilintide and semaglutide versus tirzepatide in people with type 2 diabetes taking metformin or SGLT2 inhibitor

    Recruiting

    1 1 1 1
    Germany Greece Hungary Poland Romania Spain
  • Study of semaglutide and finerenone for kidney and blood vessel protection in adults with chronic kidney disease, with or without diabetes

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark
  • Study on the Effects of Ertugliflozin and Semaglutide on Heart Health in Patients with Type 2 Diabetes

    Recruiting

    1 1 1 1
    Italy
  • Study on the Effect of Semaglutide on Healing Foot Ulcers in Patients with Type 2 Diabetes

    Recruiting

    1 1
    Investigated drugs:
    Denmark
  • Study on the Effects of Semaglutide on Mood in Patients with Major Depressive Disorder and Overweight or Obesity

    Recruiting

    1 1 1
    Investigated diseases:
    Denmark

Glossary

  • Phase 1: An early study phase that usually looks at how the treatment behaves in the body and checks basic safety in a small group.
  • Phase 2: A study phase that starts to test whether the treatment may work for a condition and continues to look at safety.
  • Phase 3: A larger study phase that compares the treatment with placebo, standard care, or another treatment to confirm benefit and safety.
  • Low intervention: A study with limited extra intervention beyond usual care or simple study procedures.
  • Placebo: A look-alike treatment with no active medicine, used to compare results fairly.
  • Primary outcome: The main result the study is designed to measure.
  • HbA1c: A blood test that shows average blood sugar over the past 2 to 3 months.
  • BMI: Body mass index, a measure that uses height and weight to classify body size.
  • UACR: Urine albumin-to-creatinine ratio, a urine test that helps show kidney damage.
  • MACE: Major adverse cardiovascular events, usually a group of serious heart and blood vessel events such as heart attack, stroke, or cardiovascular death.
  • Biomarker: A measurable sign in the body, such as a blood, urine, or tissue test result, used to track disease or treatment effect.
  • Randomized: Participants are assigned by chance to different study groups.

References

  1. https://clinicaltrials.gov/study/2025-522503-18-00
  2. https://clinicaltrials.gov/study/2025-520802-37-00
  3. https://clinicaltrials.gov/study/2025-522970-35-00
  4. https://clinicaltrials.gov/study/2022-500007-52-00
  5. https://clinicaltrials.gov/study/2025-522525-34-00
  6. https://clinicaltrials.gov/study/2022-502679-43-00
  7. https://clinicaltrials.gov/study/2022-500143-21-01
  8. https://clinicaltrials.gov/study/2022-501072-25-02
  9. https://clinicaltrials.gov/study/2023-505857-42-00
  10. https://clinicaltrials.gov/study/2023-506827-26-00
  11. https://clinicaltrials.gov/study/2023-506109-20-00
  12. https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-oral-semaglutide-for-patients-with-high-blood-sugar-after-kidney-transplantation-2/
  13. https://clinicaltrials.gov/study/2023-504913-65-01
  14. https://clinicaltrials.gov/study/2023-503371-25-00
  15. https://clinicaltrials.gov/study/2023-505959-45-00