GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT05533632

CompletedPhase 4Results posted

Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes

Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

104

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10%

Primary endpoint

•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05533632

Org study IDNN9535-4844

Secondary IDU1111-1281-5677World Health Organization (WHO)

Timeline

Milestones

Study start2022-04-25actual

Study first posted2022-09-09actual

Primary completion2024-01-18actual

Study completion2024-01-18actual

Results first posted2025-02-10actual

Last update posted2025-09-24actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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.

•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).

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Renal / kidney

Weight & body composition

8 endpoints

Secondary/registry result

Change in Body Weight (Kilogram [Kg])

Time frame:Baseline (week 1), week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Semaglutide	-5.3	—

Secondary/registry result

Change in Waist Circumference [Centimeter (cm)]

Time frame:Baseline (week 1), week 24

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Semaglutide	-5.7	—

Secondary/registry result

Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No)

Time frame:From baseline (week 1) to week 24

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	56	—
	36	—

Secondary/registry result

Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No)

Time frame:From baseline (week 1) to week 24

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	17	—
	75	—

Secondary/protocol endpoint

Change in Body Weight (Kilogram [Kg])

Time frame:Baseline (week 1), week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference [Centimeter (cm)]

Time frame:Baseline (week 1), week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No)

Time frame:From baseline (week 1) to week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No)

Time frame:From baseline (week 1) to week 24

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (week 1), week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide	-1.6	—

Secondary/registry result

Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]

Time frame:From baseline (week 1) to week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	52	—
	40	—

Secondary/registry result

Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]

Time frame:Baseline (week 1), week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide	-26.2	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (week 1), week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]

Time frame:From baseline (week 1) to week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]

Time frame:Baseline (week 1), week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Renal / kidney

4 endpoints

Secondary/registry result

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

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Value (mean), mL/min per 1.73 m^2	95% CI
Semaglutide	-1.1	—

Secondary/registry result

Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]

Time frame:Baseline (week 1), week 24

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (mean), mg/g	95% CI
Semaglutide	-18.0	—

Secondary/protocol endpoint

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

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]

Time frame:Baseline (week 1), week 24

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

10 endpoints

Secondary/registry result

Change in Total Cholesterol (mg/dL)

Time frame:Baseline (week 1), week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide	-14.1	—

Secondary/registry result

Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)

Time frame:Baseline (week 1), week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide	-12.5	—

Secondary/registry result

Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)

Time frame:Baseline (week 1), week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide	-1.1	—

Secondary/registry result

Change in Triglycerides (mg/dL)

Time frame:Baseline (week 1), week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide	-13.8	—

Secondary/registry result

Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment

Time frame:Baseline (week 1), week 24

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute (bpm)	95% CI
Semaglutide	2.9	—

Secondary/protocol endpoint

Change in Total Cholesterol (mg/dL)

Time frame:Baseline (week 1), week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)

Time frame:Baseline (week 1), week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)

Time frame:Baseline (week 1), week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Triglycerides (mg/dL)

Time frame:Baseline (week 1), week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment

Time frame:Baseline (week 1), week 24

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

16 endpoints

Primary/registry result

Number of Adverse Events (AEs)

Time frame:From baseline (Day 1) up to 24 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide	45	—

Primary/protocol endpoint

Number of Adverse Events (AEs)

Time frame:From baseline (Day 1) up to 24 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

Participants Discontinued Due to Adverse Events (Treatment Discontinuation)

Time frame:From baseline (week 1) to week 24

Discontinuation due to AE

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	4	—

Secondary/registry result

Number of Severe Hypoglycaemic Episodes

Time frame:From baseline (week 1) to week 24

Severe hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide	0	—

Secondary/registry result

Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:From baseline (week 1) to week 24

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
SemaglutideSevere	0	—
Symptomatic	2	—

Secondary/registry result

Number of Serious Adverse Events (SAEs)

Time frame:From baseline (week 1) to week 24

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide	1	—

Secondary/registry result

Number of Adverse Reactions (ARs)

Time frame:From baseline (week 1) to week 24

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide	39	—

Secondary/registry result

Number of Serious Adverse Reactions (SARs)

Time frame:From baseline (week 1) to week 24

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide	0	—

Secondary/registry result

Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant

Time frame:From baseline (week 1) to week 24

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide	0	—

Secondary/protocol endpoint

Participants Discontinued Due to Adverse Events (Treatment Discontinuation)

Time frame:From baseline (week 1) to week 24

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of Severe Hypoglycaemic Episodes

Time frame:From baseline (week 1) to week 24

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:From baseline (week 1) to week 24

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:From baseline (week 1) to week 24

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Adverse Reactions (ARs)

Time frame:From baseline (week 1) to week 24

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Reactions (SARs)

Time frame:From baseline (week 1) to week 24

event count, event

Secondary/protocol endpoint

Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant

Time frame:From baseline (week 1) to week 24

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.