Overweight and obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study will apply stratified randomisation through the LaunchDarkly program in order to achieve comparable representation of the various BMI categories, age categories and ethnicities in both treat
Sponsors
Eucalyptus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Between 18 years and 70 years of age at the time of completing the program’s pre-questionnaire 2. Satisfy the Medicines and Healthcare products Regulatory Agency (MHRA) guidelines for tirzepatide (Mounjaro) weight management 3. BMI of 30kg/m² or more (obesity), or a BMI between 27-30kg/m² (overweight) and also have weight-related health problems such as prediabetes, high blood pressure, high cholesterol, or heart problems
Exclusion criteria
Exclusion criteria: 1. Outside the 18-70 year age bracket 2. Does not have a BMI of 30 kg/m2 or more, or a BMI of 27-30 kg/m2 with at least one weight-related comorbidity such as pre-diabetes, high blood pressure, high cholesterol, heart problems 3. Has already started tirzepatide treatment as a current subscriber to the Eucalyptus weight-loss program 4. Failure to provide baseline measurements within three weeks of receiving confirmation of trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body weight measured via medical scales at baseline, 6 months post-trial commencement, and 6 months following the end of treatment 2. Ratio of fat-free mass to fat mass measured via DEXA scan at baseline, 6 months post-trial commencement, and 6 months following the end of treatment 3. Composite strength (isometric squat, push and mid-thigh pull) measured via force plates at baseline, 6 months post-trial commencement, and 6 months following the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Side effect incidence (e.g., gastrointestinal issues, stomach issues, dizziness, anxiety, fever, skin rash, etc) assessed by an independent doctor (via video consult) at any stage of the trial 2. Pathology results, including fasting glucose, fasting insulin, HbA1c and fasting lipid levels, measured via a blood test at baseline, 6 months post-trial commencement, and 6 months following the end of treatment 3. BMI: measured via medical scales and stadiometer (weight [kg]/height^2 [metres]) at baseline, 6 months post-trial commencement, and 6 months following the end of treatment | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactLouis Talay
Outcome results
None listed