Health TrialsbyHealthPanel

Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity

ConditionsOverweight , ObesityObesity (Disorder)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice.

In this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are:

* How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching? * How is the medication dosed in daily practice? Researchers will use data from electronic health records of patients in multiple outpatient locations of the Dutch Obesity Clinic (NOK, Nederlandse Obesitas Kliniek).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (age ≥18 years old)

A BMI of ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 with at least one obesity complication (e.g., hypertension, dyslipidaemia)

Disqualifiers

Pregnant women or pregnancy during treatment

Previously treated for obesity (with pharmacotherapy, endoscopic treatment or metabolic-bariatric surgery)

Patients with diabetes

Trial population

Outpatient clinic

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Tirzepatide

    Drug

    Initiating treatment with tirzepatide

Treatment groups

1,700 Participants
are divided into 1 treatment group
Group A: People with obesity1 intervention

Trial outcomes

Primary outcomes

1

Weight change

%TWL= (start weight - 6 month weight/baseline weight)\*100%

Time frame
Baseline-6 months

Secondary outcomes

1

Changes in body composition

Fat percentage (FP) and fat free mass (FFM)

Time frame
Basline-6 months
2

Demographic and clinical characteristics

* Age * Gender * Treatment location * Obesity associated diseases: hypertension, dyslipidaemia, sleep apnoea and osteoarthritis * Previous lifestyle treatment for obesity

Time frame
Baseline
3

Weight loss by maintenance dose

Maintenance dose (10mg and 15mg)

Time frame
Baseline-6 months
4

Tirzepatide dosing patterns

Including the initial prescribed dose and subsequent dose escalations throughout the treatment course

Time frame
Baseline-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Nederlandse Obesitas Kliniek

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: