ClinicalTrials.gg
Active, not recruitingNCT06790160Updated Oct 6, 2026

Study of Patients Being Treated With Anti-obesity Medication

An observational study in Obesity and Overweight, sponsored by Texas Tech University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Texas Tech University · Observational

Updated Oct 6, 2026Now Active, not recruitingPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Obesity by Texas Tech University — 3 open to participants now, 4 under way, none of them phase 3. Obesity · Texas Tech University.

Started
2025
with 1 other
Observational
2 of 21
none open now
Registered
19th of 21
by date

Among the 21 studies in Obesity by Texas Tech University, this one is one of 2 that started in 2025, is one of 2 observational ones, and was the 19th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

3 of the 21 studies in Obesity by Texas Tech University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Obesity by Texas Tech University, or all of them as a file.
02

Study summary

The goal of this observational study is to learn about the real-world effects of selected obesity medications in adults undergoing medical weight management. The main outcomes of interest are changes in body composition, routine clinical markers, muscular performance, and nutritional intake over the course of treatment. Additionally, the influence of lifestyle factors on changes in these outcome variables will be examined.

Participants beginning treatment with selected obesity medications will undergo periodic body composition and muscular performance testing, as well as complete online surveys about their nutritional intake and physical activity and exercise participation. Additionally, routinely collected clinical information will be evaluated.

Read the detailed description

Background. The popularity of anti-obesity medications, particularly glucagon-like peptide-1 receptor agonists (GLP-1RAs) like semaglutide and dual GLP-1/GIP receptor agonists like tirzepatide, has increased dramatically over the past several years. These medications are routinely prescribed in obesity management clinics and other medical settings. While controlled clinical trials have been conducted for specific drugs, many of these have not reported relevant outcomes, such as body composition changes, muscular performance, and nutritional intake. Additionally, these controlled clinical trials may not fully represent the "real world" effects of treatment in varied settings. As such, there is a need for observational, real-world evaluations of the effects of GLP-1RA and GLP-1/GIP drugs on body composition, muscular performance, nutritional intake, and routine clinical markers. Additionally, the influence of lifestyle factors, such as exercise participation, on the observed changes in these outcomes should be evaluated.

Overview. Eligible participants beginning treatment with selected obesity medications (semaglutide or tirzepatide) at a specified virtual health clinic will undergo periodic body composition and muscular performance testing, as well as complete online surveys about their nutritional intake and physical activity and exercise participation. Additionally, routinely collected clinical information will be evaluated.

Body Composition Assessment. Participants will be asked to report an approved local DXA testing facility for a baseline body composition assessment as close as possible to the beginning of their anti-obesity medication treatment. Participants will be requested to report for another scan after \~6 months of treatment, as well as after \~17 months of treatment (provided they are still undergoing treatment at this point).

Handgrip Strength Testing. Handgrip testing will take place using a standard, consumer-grade at-home handgrip dynamometer, which will be provided to each participant. Participants will be provided with instructions for conducting the handgrip testing. This testing will be completed at baseline (as close as possible to the initiation of anti-obesity medication), and after \~3, \~6, and \~17 months of treatment (provided they are still undergoing treatment at these time points).

Questionnaires. The following questionnaires will be completed at baseline (as close as possible to the initiation of anti-obesity medication), and after \~3, \~6, and \~17 months of treatment (provided they are still undergoing treatment at these time points):

  1. Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool
  2. The International Physical Activity Questionnaire (IPAQ)
  3. The Muscle-Strengthening Exercise Questionnaire (MSEQ)

Standard Clinical Markers. Some clinical markers routinely collected during standard medical treatment will also be evaluated, including a lipid panel (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), hemoglobin A1C, glucose, and blood pressure.

Power Analysis. A priori power analyses were conducted for repeated-measures ANOVA (within-subjects factors) using G*Power to determine the required sample size. The analyses used a conservative effect size (f = 0.25; "medium" strength), an alpha error probability (α) of 0.05, a desired statistical power (1-β) of 0.8, and specified one group. Ranges of number of repeated measures (2 to 4), correlations between repeated measures (0.25 to 0.5), and nonsphericity corrections (ε; 0.8 to 1) were implemented. These analyses indicated the total sample size required to achieve adequate power ranged from 24 to 50 participants. A priori power analyses were conducted for linear multiple regression (R2 deviation from zero) using G*Power to determine the required sample size for analyses examining predictors of variation in changes in outcome variables. A medium strength effect size (f2=0.15), an alpha error probability (α) of 0.05, and a desired statistical power (1-β) of 0.8 were specified. This analysis indicated that up to 6 predictors could be included in the regression model at a sample size of 98 participants. Based on consideration of these analyses, a target sample size of 100 was specified.

Statistical Analysis. Comprehensive descriptive data will be presented. Changes in all outcome variables over time will be quantified using appropriate statistical methods (e.g., repeated-measures ANOVA or a similar linear model). Additionally, the potential influence of lifestyle factors - particularly nutritional intake, physical activity level, and participation in muscle-strengthening activities - and medication type (semaglutide vs. tirzepatide) on outcome measures will be explored using an appropriate method (e.g., multiple linear regression or a related linear model, such as a linear mixed-effects model).

03

Conditions studied

  • Obesity and Overweight

Keywords

  • obesity
  • GLP-1
  • body composition
  • nutrition
  • exercise
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population is eligible individuals who are undergoing standard obesity medication treatment at a specified virtual obesity medicine practice.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient who is beginning treatment through Vineyard Virtual Health Clinic using semaglutide or tirzepatide. While the physician will individualize the treatment plans, the criteria for these medications will include, at a minimum: (A) a ≥30 kg/m2; OR (B) a BMI ≥27 kg/m2 plus at least one comorbidity.
  • Patient who lives in drivable proximity to a city with an accepted DXA testing facility and is willing to report to the facility for periodic body composition testing.

Exclusion criteria

Exclusion Criteria:

  • Patients with type 2 diabetes.
  • Patients who report not being willing or able to complete the assessments included in this research study.
  • Patients who are currently pregnant or trying to become pregnant.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients undergoing obesity treatment

    This cohort will be comprised of individuals who are beginning obesity medication treatment at a specified virtual obesity medicine practice. Patients taking semaglutide or tirzepatide may be eligible for inclusion in this cohort.

This study also gives Semaglutide, Tirzepatide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Change in Total Lean Soft Tissue

    Change in total lean soft tissue assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

  2. Change in Appendicular Lean Soft Tissue

    Change in appendicular lean soft tissue assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

  3. Change in Total Fat Mass

    Change in total fat mass assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

  4. Change in Handgrip Strength

    Change in maximal handgrip strength as determined by a handgrip dynamometer.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

Secondary outcomes

  1. Change in Total Body Mass

    Change in total body mass assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

  2. Change in Total Body Fat Percentage

    Change in total body fat percentage assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

  3. Change in Total Bone Mineral Content

    Change in total bone mineral content assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

  4. Change in Visceral Fat

    Change in visceral fat assessed by dual-energy X-ray absorptiometry.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~6 months and ~17 months after baseline).

Other outcomes

  1. Change in Total Cholesterol

    Change in total cholesterol as assessed by a lipid panel.

    Time frame: From baseline assessment to last available time point.

  2. Change in LDL Cholesterol

    Change in low-density lipoprotein cholesterol as assessed by a lipid panel.

    Time frame: From baseline assessment to last available time point.

  3. Change in HDL Cholesterol

    Change in high-density lipoprotein cholesterol as assessed by a lipid panel.

    Time frame: From baseline assessment to last available time point.

  4. Change in Triglycerides

    Change in triglycerides as assessed by a lipid panel.

    Time frame: From baseline assessment to last available time point.

  5. Change in Hemoglobin A1C

    Change in hemoglobin A1C as assessed by a routine blood panel.

    Time frame: From baseline assessment to last available time point.

  6. Change in Glucose

    Change in blood glucose as assessed by a blood panel.

    Time frame: From baseline assessment to last available time point.

  7. Change in Blood Pressure

    Change in blood pressure as assessed by sphygmomanometry.

    Time frame: From baseline assessment to last available time point.

  8. Energy Intake

    Total energy intake as assessed by the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  9. Protein Intake

    Total protein intake as assessed by the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  10. Carbohydrate Intake

    Total carbohydrate intake as assessed by the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  11. Fat Intake

    Total fat intake as assessed by the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  12. Fiber Intake

    Total fiber intake as assessed by the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  13. Sugar Intake

    Total sugar intake as assessed by the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool.

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  14. Muscle-strengthening activity level

    Degree of participation in muscle-strengthening activities as assessed by the Muscle-Strengthening Exercise Questionnaire (MSEQ)

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

  15. Physical activity level

    Physical activity level as assessed by the International Physical Activity Questionnaire (IPAQ)

    Time frame: From baseline assessment to last available time point (follow-up assessments conducted ~3, ~6, and ~17 months after baseline).

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Mar 2028, 38 months after the start.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 38 months is close to that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Dec 2027 → Mar 2028 and completion Dec 2027 → Mar 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2025
First posted
Jan 23, 2025
StartActual
Jan 31, 2025
Primary completionEst.
Mar 2028was Dec 2027
CompletionEst.
Mar 2028was Dec 2027
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 6, 2026
Primary completion
Dec 2027→Mar 2028
Oct 6, 2026
Study completion
Dec 2027→Mar 2028
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Active, not recruiting
    Primary completion Dec 2027→Mar 2028
    Study completion Dec 2027→Mar 2028
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06790160
Lead sponsor
Texas Tech University
Collaborators
Vineyard Health Inc.
Responsible party
Sponsor
First posted
Jan 23, 2025
Start date
Jan 31, 2025
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Oct 6, 2026
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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