MitoSema

UnknownPhase 4

Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes

Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes - Effects on Glucose Metabolism, Prevention of Weight Regain and Peripheral Tissue Metabolic Activation

Lead sponsor

Kirsi Pietiläinen

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥27•HbA1c ≥6%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04854083

Org study ID2020

Timeline

Milestones

Study first posted2021-04-22actual

Study start2022-02-17actual

Last update posted2022-03-31actual

Primary completion2025-08estimated (month precision)

Study completion2025-08estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥18 years and <65 years

•BMI: ≥27 kg/m2

•T2DM (HbA1c ≥ 6.0% if on anti-diabetic medication or HbA1c≥6.5% if non- medicated)

•Participant is willing and able to give informed consent for participation in the study

Exclusion criteria

•Contraindication to trial drugs

•Use of insulin or GLP-1RAs (during the past 3 months)

•Use of anti-obesity drugs (during the past 3 months)

•Weight change of >5% during the past 3 months

•Bariatric surgery or planned bariatric surgery during the trial

•History of pancreatitis

•Impaired renal function (GFR<30 ml/min/1.73m2)

•Impaired hepatic function (ALAT>2 x upper limit normal)

•Clinically significant active cardiovascular disease

•Clinically significant abnormality in the ECG

•Cancer (except basal or squamous cell skin cancers)

•Major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia)

•Substance abuse

•Learning disability

•Females of childbearing potential not using adequate contraceptive methods

•Pregnancy

•Lactation

•Any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results

Endpoints (17)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Other (unclassified)

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Body weight

Time frame:from baseline to 6 and 12 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of patients reaching ≥5%,10% & 15% weight loss

Time frame:from baseline to 6 and 12 months

threshold achievement, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:from baseline to 6 and 12 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

HbA1c

Time frame:from baseline to 12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c

Time frame:from baseline to 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting plasma glucose

Time frame:from baseline to 6 and 12 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes in concomitant antidiabetic medications

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Blood pressure

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Plasma lipids

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Changes in concomitant antihypertensive medications

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Changes in concomitant lipid medications

Time frame:from baseline to 6 and 12 months

change from baseline, descriptive

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change in appetite and eating habits, control of eating

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in appetite and eating habits, emotional, external and restraint eating

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Change in appetite and eating habits, binge eating

Time frame:from baseline to 6 and 12 months

change from baseline, improvement

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Mitochondrial DNA quantification

Time frame:from baseline to 6 and 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in the transcriptomics profile of adipose tissue and skeletal muscle

Time frame:from baseline to 6 and 12 months

change from baseline, descriptive

Secondary/protocol endpoint

Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver

Time frame:from baseline to 12 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 6, 2026 snapshot.