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Can Weight-Loss drugs outperform diet and exercise for heart health?

NCT ID NCT07740291

Disease control Sponsor: Texas Tech University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study compares two weight-loss strategies: GLP-1 medications (like semaglutide or tirzepatide) versus a structured diet and exercise program. Adults with a BMI of 27.5 or higher are followed for three months to see which approach better improves heart and metabolic markers, such as blood sugar, cholesterol, and blood pressure. The trial also looks at changes in appetite hormones, gene activity, and mental well-being, including eating behaviors and stress. The goal is to understand the broader health impacts of each method beyond just weight loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GLP-1 receptor agonist medications (semaglutide or tirzepatide) compared with a structured lifestyle intervention (reduced-calorie diet and increased physical activity)
What this could lead to
If successful, this could clarify which weight-loss approach—medication or lifestyle—better improves heart and metabolic health, and may guide personalized treatment choices for obesity.
What could go wrong
This is a small pilot study, so results may not be conclusive or generalizable. The medication group is not randomized, and dosing is determined by each participant's own doctor, which could introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * BMI of 27.5 kg/m2 or higher * For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider * For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months Exclusion Criteria: * Pregnant * Breastfeeding * Wears a pacemaker or other internal medical device * Chronic kidney disease in the past 2 years * Active cancer or cancer treatment within the past 6 months * Current diagnosis of any major endocrine, inflammatory, cardiovascular, or neurological disorder/condition, including Addison's disease, autism, congestive heart failure, Crohn's disease, Cushing's syndrome, hyperparathyroidism, multiple sclerosis, neuromuscular disorders (Guillain-Barre syndrome or myasthenia gravis), stroke, thyroid gland disorders (hyperthyroidism or hypothyroidism), type 1 diabetes, and ulcerative colitis * Insulin therapy for type 2 diabetes * For LS comparator arm only: initiating any weight-loss medication (including a GLP-1 receptor agonist) currently or within the past 3 months

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive eating disorder Feeding and Eating Disorders mental disorder Obesity obesity disorder Overweight Psychological Well-Being

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Addiction Cardiometabolic health indicators Eating disorders Mental health Obesity & overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nutrition Metabolic Health Initiative (NMHI)

    RECRUITING

    Lubbock, Texas, 79410, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.