Obesity in DiabetesPhase 3OBES1TYNCT06909006
Semaglutide Treatment in Type 1 Diabetes
A Phase 3 study testing Semaglutide 2.4mg in people with Obesity in Diabetes and Obesity/Therapy, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity in Diabetes, Obesity/Therapy, Type 1 Diabetes Mellitus (T1DM)
- What is being tested?
- Semaglutide 2.4mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2025to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Type 1 Diabetes for more than 3 years
- BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis
Who cannot join
- Treated with GLP1-RAs within last 6 months
- Known intolerance for semaglutide
- Other forms of diabetes
- Pregnant or nursing women
- Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
- Liver disease with elevated plasma alanine aminotransferase (ALT) > five times and plasma aspartate aminotransferase (AST) > five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
Show all 12Show fewer
- Acute or chronic pancreatitis
- Cancer, unless in complete remission for > 5 years or unless basocellular carcinomas
- History of thyroid adenoma or carcinoma
- Alcohol/drug abuse
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Receipt of an investigational drug within 30 days prior to visit 0 / Simultaneous participation in any other clinical intervention trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas F Dejgaard, MD, ph.d., endocrinologist contact
Denmark1 site
Nordsjaellands Hospital
Hillerød, Denmark, 3400
Thomas F Dejgaard, MD, ph.d., endocrinologist, 0045 26 79 61 03, Thomas.fremming.dejgaard@regionh.dk
Hasan I Mirza, MD, ph.d.-student, 0045 42 37 58 40, hasan.imran.mirza@regionh.dk
About this study
Official title: Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial
The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.
Read the detailed description
This is a multicentre, randomised, double-blinded, placebo-controlled and investigator-initiated trial aimed to investigate the efficacy of semaglutide in patients with Type 1 Diabetes.
Patients from all included diabetes care centres will at routine visits be screened for eligibility for the trial and offered participation. If accepted, the patients will be randomised to one of two intervention arms and undergo a series of different examinations prior to start of the intervention.
The two arms consist of treatment with subcutaneous semaglutide injections or subcutaneous injections with semaglutide placebo. The baseline examinations entail documentation of insulin doses, dietary patterns, diabetes distress and treatment satisfaction questionnaires, anthropoimetric data (height, weight and calculation of BMI, waist circumference, waist-hip-ratio), blood work (HbA1c, fasting glucose, fasting c-peptide, lipids, liver and kidney markers incl. Fib-4-scoring, hematology, hsCRP), ECG, capturing of data from continuous/flash glucose monitors.
The first 40 included in the study from the centres of SDCA and NOH will further be examined through hyperinsulinemic euglycemic clamps to determine their insulin sensitivity and asses their transcriptome through muscle and fat cell biopsies in relation to the clamp and also be assessed through DXA scans to look at body composition and bone density.
Patients will then be handed out their trial drug-pens and start the uptitration proces.
The efficacy of semaglutide will be evaluated through the above mentioned array of different investigations by comparing parameters prior to trial drug start, during (throughout the study period), at the end of the drug and at a 6 week post-study followup in an intention-to-treat analysis primarily and secondarily a per-protocol analysis.
The safety will be assessed through evaluation of standardized adverse event reporting (including hypoglycemic events and diabetic ketoacidosis).
- Conditions
- Obesity in Diabetes, Obesity/Therapy, Type 1 Diabetes Mellitus (T1DM), Insulin Sensitivity/Resistance, Semaglutide, Lipidomics
- Being tested
- Semaglutide 2.4mg, Semaglutide placebo
- Keywords
- Semaglutide, Obesity, Type 1 Diabetes, Obese Type 1 Diabetics, Insulin sensitivity, Insulin resistance, Weight loss, GLP1-RA, GLP1, Wegovy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 1, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4mgDrug
Also called Active semaglutide
The active comparator of the intervention is s.c. Semaglutide injection once a week in increasing doses every month from 0.25 mg to 0.5 mg to 1.0 mg to 1.7 mg to 2.4 mg and the placebo comparator is s.c. injection with a visually identical and same label pen as described for the active comparator
Semaglutide placeboDrug
Also called Placebo semaglutide
Visually identical and same label as the active comparator intervention
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Active comparator | Subcutaneous injection through injector pen with the active comparator Semaglutide once a week in monthly increasing doses as given: 0.25mg - 0.5mg - 1.0mg - 1.7mg - 2.4mg Receives: Drug: Semaglutide 2.4mg |
| Semaglutide placebo | Placebo comparator | Visually identical injector pen without the active comparator. Receives: Drug: Semaglutide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be measured both prior to and following treatment for 68 weeks with either semaglutide or placebo. Changes in body weight will be compared for the two intervention arms, before, throughout and at the end of treatment and then at followup 6 weeks later.
Measured: 74 weeks
Secondary outcomes (42)
Systolic blood pressure
Systolic blood pressure will be assessed at randomization and evaluated for changes throughout, at the end of treatment and at followup 6 weeks later.
Measured: 74 weeks
Diastolic blood pressure
Diastolic blood pressure will be assessed at randomization and evaluated for changes throughout, at the end of treatment and at followup 6 weeks later.
Measured: 74 weeks
Resting heart rate
Systolic blood pressure will be assessed at randomization and evaluated for changes throughout, at the end of treatment and at followup 6 weeks later.
Measured: 74 weeks
Waist circumference
Waist circumference will be assessed and evaluated for changes during and after treatment for 68 weeks with semaglutide compared to before treatment.
Measured: 74 weeks
Hip-waist-ratio
Hip-waist-ratio will be assessed and evaluated for changes during and after treatment for 68 weeks with semaglutide compared to before treatment.
Measured: 74 weeks
Hemoglobin
Blood samples will be analyzed to assess hemoglobin before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Leucocytes
Blood samples will be analyzed to assess leucocytes levels before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Thrombocytes
Blood samples will be analyzed to assess thrombocytes levels before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
HbA1c
Blood samples will be analyzed to assess HbA1c before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Fasting plasma-glucose
Blood samples will be analyzed to assess fasting plasma-glucose before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Fasting c-peptide
Blood samples will be analyzed to assess fasting c-peptide before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Total cholesterol
Blood samples will be analyzed to assess total cholesterol before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
HDL cholesterol
Blood samples will be analyzed to assess HDL cholesterol before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74
LDL cholesterol
Blood samples will be analyzed to assess LDL cholesterol before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
VLDL cholesterol
Blood samples will be analyzed to assess VLDL cholesterol before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Triglycerides
Blood samples will be analyzed to assess triglycerides levels before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
non-HDL cholesterol
Blood samples will be analyzed to assess non-HDL cholesterol before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Sodium
Blood samples will be analyzed to assess sodium before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Potassium
Blood samples will be analyzed to assess potassium before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Creatinine/eGFR
Blood samples will be analyzed to assess creatinine levels to calculate estimated Glomerular Filtration Rates (eGFR, based on sex, age and creatinine leve) before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Alanine transaminase (ALT)
Blood samples will be analyzed to assess alanine transaminase (ALT) before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Aspartate transaminase (AST)
Blood samples will be analyzed to assess aspartate transaminase (AST) before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Fibrosis-4-score (Fib-4)
Blood samples will be analyzed for fibrosis-4-scores (based on age, thrombocytes, ALT and AST) before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Amylase
Blood samples will be analyzed to assess pancreatic amylase before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Lipase
Blood samples will be analyzed to assess pancreatic lipase before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
High sensitivity C-reactive protein (hsCRP)
Blood samples will be analyzed to assess high sensitivity C-reactive protein (hsCRP) before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Albumin
Blood samples will be analyzed to assess serum albumin before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up.
Measured: 74 weeks
Ketones
Blood samples will be analyzed to assess total serum ketones before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up
Measured: 74 weeks
CGM data - Time in range (TIR)
Data from CGMs will be analyzed to asses time in range (TIR) before treatment and evaluated for changes in TIR throughout the 68-week regimen and at its conclusion.
Measured: 68 weeks
CGM data - Time in tight range (TITR)
Data from CGMs will be analyzed to asses time in tight range (TITR) before treatment and evaluated for changes in TITR throughout the 68-week regimen and at its conclusion.
Measured: 68 weeks
CGM data - Time above range (TAR)
Data from CGMs will be analyzed to asses time above range (TAR) before treatment and evaluated for changes in TAR throughout the 68-week regimen and at its conclusion.
Measured: 68 weeks
CGM data - Time below range (TBR)
Data from CGMs will be analyzed to asses time in range (TBR) before treatment and evaluated for changes in TBR throughout the 68-week regimen and at its conclusion.
Measured: 68 weeks
CGM data - coefficient of variation (CV)
Data from CGMs will be analyzed to asses coefficient of variation (CV) before treatment and evaluated for changes in CV throughout the 68-week regimen and at its conclusion.
Measured: 68 weeks
Total daily dose of insulin
Total daily dose will be assessed at randomization and evaluated for changes throughout treatment regimen, at the end of study and at six weeks followup through the use of insulin dose diaries.
Measured: 74 weeks
Insulin sensitivity
For a subgroup consisting of the first 40 patients from two specified sites: Insulin sensitivity will be assessed through the golden standard hyperinsulinemic euglycemic clamping method. This will be done before treatment and at the end of treatment.
Measured: 68 weeks
Fat percentage
For a subgroup consisting of the first 40 patients from two specified sites: The fat percentage is measured by DXA scan at randomisation and at end-of-treatment.
Measured: 68 weeks
Lean mass
For a subgroup consisting of the first 40 patients from two specified sites: Lean body mass is measured by DXA scan at randomisation and at end-of-treatment.
Measured: 68 weeks
Bone density (through bone mineral content)
For a subgroup consisting of the first 40 patients from two specified sites: Bone density (through bone mineral content) is measured by DXA scan at randomisation and at end-of-treatment.
Measured: 68 weeks
Omics / Metabolome
For a subgroup consisting of the first 40 patients from two specified sites: Blood samples will be analyzed to assess metabolomic profile (entailing both lipidome and proteome) before treatment and evaluated for changes throughout the 68-week regimen, at its conclusion, and again six weeks post-treatment during follow-up
Measured: 74 weeks
Muscle tissue biopsy
For a subgroup consisting of the first 40 patients from two specified sites: Muscle tissue biopsies will be taken to assess changes in transcriptome at randomisation and at end-of-treatment.
Measured: 68 weeks
Fat tissue biopsy
For a subgroup consisting of the first 40 patients from two specified sites: Fat tissue biopsies will be taken to assess changes in transcriptome at randomisation and at end-of-treatment.
Measured: 68 weeks
Electrocardiogram
Electrocardiograms (ECG) will be recorded at initiation and end of treatment period to assess and evaluate if any rhytm changes occur.
Measured: 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study startOct 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity in DiabetesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blinded, placebo-controlled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Steno Diabetes Center Odense, Zealand University Hospital, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Thomas F Dejgaard, MD, ph.d., endocrinologist, Study chair, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909006
- Sponsor's protocol ID
- U1111-1304-0713
- Acronym
- OBES1TY
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request for it.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial
- ClinicalTrials.gov ID
- NCT06909006
- Acronym / sponsor ID
- OBES1TY / U1111-1304-0713
- Conditions
- Obesity in Diabetes, Obesity/Therapy, Type 1 Diabetes Mellitus (T1DM), Insulin Sensitivity/Resistance, Semaglutide, Lipidomics
- Keywords
- Semaglutide, Obesity, Type 1 Diabetes, Obese Type 1 Diabetics, Insulin sensitivity, Insulin resistance, Weight loss, GLP1-RA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Steno Diabetes Center Odense, Zealand University Hospital, Aarhus University Hospital
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.
Detailed description
This is a multicentre, randomised, double-blinded, placebo-controlled and investigator-initiated trial aimed to investigate the efficacy of semaglutide in patients with Type 1 Diabetes.
Patients from all included diabetes care centres will at routine visits be screened for eligibility for the trial and offered participation. If accepted, the patients will be randomised to one of two intervention arms and undergo a series of different examinations prior to start of the intervention.
The two arms consist of treatment with subcutaneous semaglutide injections or subcutaneous injections with semaglutide placebo. The baseline examinations entail documentation of insulin doses, dietary patterns, diabetes distress and treatment satisfaction questionnaires, anthropoimetric data (height, weight and calculation of BMI, waist circumference, waist-hip-ratio), blood work (HbA1c, fasting glucose, fasting c-peptide, lipids, liver and kidney markers incl. Fib-4-scoring, hematology, hsCRP), ECG, capturing of data from continuous/flash glucose monitors.
The first 40 included in the study from the centres of SDCA and NOH will further be examined through hyperinsulinemic euglycemic clamps to determine their insulin sensitivity and asses their transcriptome through muscle and fat cell biopsies in relation to the clamp and also be assessed through DXA scans to look at body composition and bone density.
Patients will then be handed out their trial drug-pens and start the uptitration proces.
The efficacy of semaglutide will be evaluated through the above mentioned array of different investigations by comparing parameters prior to trial drug start, during (throughout the study period), at the end of the drug and at a 6 week post-study followup in an intention-to-treat analysis primarily and secondarily a per-protocol analysis.
The safety will be assessed through evaluation of standardized adverse event reporting (including hypoglycemic events and diabetic ketoacidosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blinded, placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Active comparator | Drug: Semaglutide 2.4mgSubcutaneous injection through injector pen with the active comparator Semaglutide once a week in monthly increasing doses as given: 0.25mg - 0.5mg - 1.0mg - 1.7mg - 2.4mg |
| Semaglutide placebo | Placebo comparator | Drug: Semaglutide placeboVisually identical injector pen without the active comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 Diabetes for more than 3 years
- BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis
Key exclusion criteria (12 listed)
- Treated with GLP1-RAs within last 6 months
- Known intolerance for semaglutide
- Other forms of diabetes
- Pregnant or nursing women
- Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
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 |
|---|---|---|
| Semaglutide 2.4mgAlso: Active semaglutideThe active comparator of the intervention is s.c. Semaglutide injection once a week in increasing doses every month from 0.25 mg to 0.5 mg to 1.0 mg to 1.7 mg to 2.4 mg and the placebo comparator is s.c. injection with a visually identical and same label pen as described for the active comparator | Drug | Semaglutide |
| Semaglutide placeboAlso: Placebo semaglutideVisually identical and same label as the active comparator intervention | Drug | Semaglutide placebo |
Primary outcome
Body weight
Time frame: 74 weeks
Body weight will be measured both prior to and following treatment for 68 weeks with either semaglutide or placebo. Changes in body weight will be compared for the two intervention arms, before, throughout and at the end of treatment and then at followup 6 weeks later.
42 secondary outcomes
Systolic blood pressure
Time frame: 74 weeks
Diastolic blood pressure
Time frame: 74 weeks
Resting heart rate
Time frame: 74 weeks
Waist circumference
Time frame: 74 weeks
Hip-waist-ratio
Time frame: 74 weeks
Hemoglobin
Time frame: 74 weeks
Leucocytes
Time frame: 74 weeks
Thrombocytes
Time frame: 74 weeks
HbA1c
Time frame: 74 weeks
Fasting plasma-glucose
Time frame: 74 weeks
Fasting c-peptide
Time frame: 74 weeks
Total cholesterol
Time frame: 74 weeks
HDL cholesterol
Time frame: 74
LDL cholesterol
Time frame: 74 weeks
VLDL cholesterol
Time frame: 74 weeks
Triglycerides
Time frame: 74 weeks
non-HDL cholesterol
Time frame: 74 weeks
Sodium
Time frame: 74 weeks
Potassium
Time frame: 74 weeks
Creatinine/eGFR
Time frame: 74 weeks
Alanine transaminase (ALT)
Time frame: 74 weeks
Aspartate transaminase (AST)
Time frame: 74 weeks
Fibrosis-4-score (Fib-4)
Time frame: 74 weeks
Amylase
Time frame: 74 weeks
Lipase
Time frame: 74 weeks
High sensitivity C-reactive protein (hsCRP)
Time frame: 74 weeks
Albumin
Time frame: 74 weeks
Ketones
Time frame: 74 weeks
CGM data - Time in range (TIR)
Time frame: 68 weeks
CGM data - Time in tight range (TITR)
Time frame: 68 weeks
CGM data - Time above range (TAR)
Time frame: 68 weeks
CGM data - Time below range (TBR)
Time frame: 68 weeks
CGM data - coefficient of variation (CV)
Time frame: 68 weeks
Total daily dose of insulin
Time frame: 74 weeks
Insulin sensitivity
Time frame: 68 weeks
Fat percentage
Time frame: 68 weeks
Lean mass
Time frame: 68 weeks
Bone density (through bone mineral content)
Time frame: 68 weeks
Omics / Metabolome
Time frame: 74 weeks
Muscle tissue biopsy
Time frame: 68 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be shared upon request for it.
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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.
Thomas F Dejgaard, MD, ph.d., endocrinologist contact
Thomas F Dejgaard, MD, ph.d., endocrinologist study chair
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide 2.4mg in people with Obesity in Diabetes and Obesity/Therapy, run by Nordsjaellands Hospital at 1 site in Denmark.
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 2 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas F Dejgaard, MD, ph.d., endocrinologist (0045 26 79 61 03, Thomas.fremming.dejgaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 74 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 8 Aug 2025.