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CIMT-LOSEIT-I

Completed

Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects; Weight Loss

Ultrasound Assessment of the Carotid Intimal Medial Thickness in Obese Subjects Following a Significant Weight Loss

Lead sponsor

Henrik Gudbergsen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

200

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

•BMI ≥27

Primary endpoint

•The mean posterior wall common carotid intima-media thickness in mm

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 IDNCT02954627

Org study ID137.09

Timeline

Milestones

Study first posted2016-11-03estimated

Last update posted2019-03-25actual

Study start2016-11 (month precision)

Primary completion2019-02actual (month precision)

Study completion2019-03actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years

Maximum age74 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

Inclusion criteria

•Informed consent obtained

•Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)

•Age ≥ 18 years and < 75 years

•Body mass index (BMI) ≥ 27 kg/m2

•Stable body weight during the previous 3 months (< 5 kg self-reported weight change)

•Motivated for weight loss

Exclusion criteria

•On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)

•Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial

•Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine

•Type 1 diabetes

•Type 2 diabetes treated with glucose-lowering drugs other than metformin

•Alloplasty in target knee joint (see section 6.3)

•End stage disease in target knee joint (Kellgren-Lawrence grade 4)

•Immuno-inflammatory disease

•Chronic wide-spread pain

•Pregnancy or insufficient anti-conception therapy for female fertile patients

•Breast-feeding

•Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2

•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)

•Surgery scheduled for the trial duration period, except for minor surgical procedures

•Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment

•Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)

•Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L

•Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain

•Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

•Inflammatory bowel disease

•Congestive heart failure, New York Heart Association (NYHA) class III-IV

•Diabetic gastroparesis

•History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer

•History of cancer with the exception of in-situ malignancies of the skin or cervix uteri

•History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder

•Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial

•Inability to speak Danish fluently

•A mental state impeding compliance with the program

•Use of opioids or similar strong analgesics

•Allergic reactions to the active ingredients of Saxenda, such as hypotension, palpitations, dyspnoea and oedema

Endpoints (4)

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

Cardiometabolic biomarkers

Other (unclassified)

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

Change in the mean posterior wall common carotid intima-media thickness in mm

Time frame:Week -8 to 52

change from baseline, improvement

Secondary/protocol endpoint

Change in the maximum posterior wall common carotid intima-media thickness in mm

Time frame:Week -8 to 0

change from baseline, improvement

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Change in the mean posterior wall common carotid intima-media thickness in mm

Time frame:Week -8 to 0

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in the maximum posterior wall common carotid intima-media thickness in mm

Time frame:Week -8 to 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.