Spartina® (Tirzepatide) Effectiveness and Safety Evaluation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCinnagen

About this trial

The goal of this study is to evaluate Effectiveness and safety of Spartina® (Tirzepatide) in male or female participants with obesity and overweight. The main questions which are aimed to be answered:

1. Is Spartina® (Tirzepatide) effective in the treatment of obesity and overweight? 2. Is Spartina® (Tirzepatide) safe in the treatment of obesity and overweight?

In this study, there is no comparison group. Participants receive Spartina® (Tirzepatide)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥18 years of age

Willingness for signing and having signed the informed consent form

BMI ≥30 kg/m² or ≥27 kg/m² with ≥1 weight-related comorbidity

Disqualifiers

Prior use of any GLP-1 agonist in the last 6 months

Type 1 diabetes mellitus

Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data

Pregnancy or breast-feeding

Trial population

Primary care clinic

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Proportion of patients with ≥5% weight loss

Time frame
day 0, 180

Secondary outcomes

1

Percent change in body weight from baseline

Time frame
day 0, 90
2

Absolute change in body weight from baseline

Time frame
day 0, 90
3

Percent change in body weight from baseline

Time frame
day 0, 180
4

Absolute change in body weight from baseline

Time frame
day 0, 180

Other outcomes

Sponsors and contacts

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