Diabetes Mellitus, Type 2Phase 4NCT05533632
Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes
A Phase 4 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in Chile.
Trial summary
This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesChile
- Study dates
- 25 Apr 2022to 18 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit.
- Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for ≥ 60 days prior to the screening visit.
- HbA1c 7.5-10% (59-86 millimoles per mole [mmol/mol]) (both inclusive) in Visit 1.
- Participants in which Ozempic is indicated according to approved local label.
- Fundoscopy/Fundus photography record less than equal to (≤) 12 months.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except Coronavirus Disease 2019 (COVID-19) related trials (this is allowed).
- Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Show all 18Show fewer
- Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
- History of pancreatitis (acute or chronic).
- Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 milliliters/minute (mL/min)/1.73 meter square (m^2) as per MDRD-4 (Modification of Diet in Renal Disease).
- Myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
- Participants presently classified as being in New York Heart Association (NYHA) Class IV heart failure.
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- Participants with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
- Use of systemic immunosuppressive treatment within 90 days prior to screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of ≤ 14 days.
- Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 12 months prior to screening.
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
Trial locations and contacts
3 sites in 1 country.
Chile3 sites
Servicios Médicos Godoy Limitada
Santiago, Región Metropolitana, 7500710
Hospital San Juan de Dios_Santiago, Región Metropolitana
Santiago, Región Metropolitana, 8350429
Hospital Padre Hurtado
Santiago, Región Metropolitana, 8880465
About this study
Official title: Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes
This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive semaglutide subcutaneous (s.c.) injection once weekly in a dose escalation manner for 24 weeks: 0.25 milligrams (mg) (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
Measured: From baseline (Day 1) up to 24 weeks
Secondary outcomes (21)
Change in Glycosylated Haemoglobin (HbA1c)
Change in glycosylated haemoglobin (HbA1c) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]
Participants achieving HbA1c less than 7.0% (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: From baseline (week 1) to week 24
Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]
Change in fasting plasma glucose (FPG) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in Body Weight (Kilogram [Kg])
Change in body weight from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in Waist Circumference [Centimeter (cm)]
Change in waist circumference from baseline (week 1) to week 24 is presented. Waist circumference is defined as the minimal abdominal circumference located midway between the lower rib margin and the iliac crest. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No)
Participants achieving greater than or equal (≥) 5% weight reduction (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: From baseline (week 1) to week 24
Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No)
Participants achieving greater than or equal (≥) 10% weight reduction (Yes/No) from baseline (week 1) to week is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: From baseline (week 1) to week 24
Change in Total Cholesterol (mg/dL)
Change in total cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)
Change in low density lipoprotein (LDL) cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)
Change in high density lipoprotein (HDL) cholesterol (mg/dL) cholesterol from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in Triglycerides (mg/dL)
Change in triglycerides (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)]
Change in estimated glomerular filtration rate (eGFR) [millilitre per minute (mL/min) per 1.73 square meter (m^2)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]
Change in Urine Albumin-Creatinine Ratio (UACR) [milligram per gram (mg/g)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Participants Discontinued Due to Adverse Events (Treatment Discontinuation)
Participants discontinued due to adverse events (treatment discontinuation) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
Measured: From baseline (week 1) to week 24
Number of Severe Hypoglycaemic Episodes
Number of severe hypoglycaemic episodes from baseline (week 1) to week 24 is presented. Hypoglycaemic episodes were classified as severe if there was no specific glucose threshold but were associated with severe cognitive impairment requiring external assistance for recovery. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit.
Measured: From baseline (week 1) to week 24
Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit.
Measured: From baseline (week 1) to week 24
Number of Serious Adverse Events (SAEs)
Number of serious adverse events (SAEs) from baseline (week 1) to week 24 is presented. An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; important medical event. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
Measured: From baseline (week 1) to week 24
Number of Adverse Reactions (ARs)
Number of adverse reactions (ARs) from baseline (week 1) to week 24 is presented. Adverse reaction is an undesired effect of a drug or other type of treatment that can range from mild to severe and can be life-threatening. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
Measured: From baseline (week 1) to week 24
Number of Serious Adverse Reactions (SARs)
Number of serious adverse reactions (SARs) from baseline (week 1) to week 24 is presented. Serious adverse reaction is an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
Measured: From baseline (week 1) to week 24
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant
Number of suspected unexpected serious adverse reactions (SUSARs) per participant from baseline (week 1) to week 24 is presented. SUSAR is a serious adverse event which is unexpected and regarded as possibly or probably related to the trial product. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
Measured: From baseline (week 1) to week 24
Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment
Change from baseline in heart rate (pulse) after 24 weeks of treatment is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.
Measured: Baseline (week 1), week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start25 Apr 2022
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
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
- NCT05533632
- Sponsor's protocol ID
- NN9535-4844
- Other IDs
- U1111-1281-5677
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2022
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05533632
- Acronym / sponsor ID
- NN9535-4844
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants will receive semaglutide subcutaneous (s.c.) injection once weekly in a dose escalation manner for 24 weeks: 0.25 milligrams (mg) (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit.
- Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for ≥ 60 days prior to the screening visit.
- HbA1c 7.5-10% (59-86 millimoles per mole [mmol/mol]) (both inclusive) in Visit 1.
- Participants in which Ozempic is indicated according to approved local label.
- Fundoscopy/Fundus photography record less than equal to (≤) 12 months.
Key exclusion criteria (18 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except Coronavirus Disease 2019 (COVID-19) related trials (this is allowed).
- Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.
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 |
|---|---|---|
| SemaglutideParticipants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks. | Drug | Semaglutide |
Primary outcome
Number of Adverse Events (AEs)
Time frame: From baseline (Day 1) up to 24 weeks
Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.
21 secondary outcomes
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Baseline (week 1), week 24
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]
Time frame: From baseline (week 1) to week 24
Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]
Time frame: Baseline (week 1), week 24
Change in Body Weight (Kilogram [Kg])
Time frame: Baseline (week 1), week 24
Change in Waist Circumference [Centimeter (cm)]
Time frame: Baseline (week 1), week 24
Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No)
Time frame: From baseline (week 1) to week 24
Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No)
Time frame: From baseline (week 1) to week 24
Change in Total Cholesterol (mg/dL)
Time frame: Baseline (week 1), week 24
Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)
Time frame: Baseline (week 1), week 24
Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)
Time frame: Baseline (week 1), week 24
Change in Triglycerides (mg/dL)
Time frame: Baseline (week 1), week 24
Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)]
Time frame: Baseline (week 1), week 24
Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]
Time frame: Baseline (week 1), week 24
Participants Discontinued Due to Adverse Events (Treatment Discontinuation)
Time frame: From baseline (week 1) to week 24
Number of Severe Hypoglycaemic Episodes
Time frame: From baseline (week 1) to week 24
Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: From baseline (week 1) to week 24
Number of Serious Adverse Events (SAEs)
Time frame: From baseline (week 1) to week 24
Number of Adverse Reactions (ARs)
Time frame: From baseline (week 1) to week 24
Number of Serious Adverse Reactions (SARs)
Time frame: From baseline (week 1) to week 24
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant
Time frame: From baseline (week 1) to week 24
Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment
Time frame: Baseline (week 1), week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in Chile.
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 5 inclusion and 18 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events (AEs) (time frame: From baseline (Day 1) up to 24 weeks). 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 24 Sep 2025.