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Can a phone app plus Weight-Loss drugs help people shed pounds and improve heart health?

NCT ID NCT07588984

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether combining GLP-1 medications (like semaglutide and tirzepatide) with Noom's app-based behavioral program helps people lose weight and improve heart health markers. Over 2,300 adults will be followed for 24 months, tracking weight, blood sugar, cholesterol, and side effects. The goal is to see how well these approaches work in everyday life.

What this could mean

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

Active substance
Semaglutide and tirzepatide (GLP-1 medications), combined with Noom's app-based behavioral program
What this could lead to
If successful, this could show that combining GLP-1 drugs with a digital behavioral program leads to better weight loss and heart health in real-world settings.
What could go wrong
This is an observational study, not a randomized controlled trial, so results may be less reliable. Side effects from GLP-1 drugs (like nausea) are common, and long-term weight maintenance is uncertain.

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.

Participants

About 2,310 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population includes individuals enrolled in Noom commercially available programs and individuals interested in weight loss not enrolled in a weight management program (education-only control group).

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Speaks English * Community-dwelling, community-living status * Able to ambulate independently, with or without aids or devices * Unless medically indicated, willingness to stay on current program for 12 months and participate in all study activities * Provides informed consent for study participation * Commitment and willingness to participate, as assessed by completion of decisional balance exercise * Program-specific eligibility: * Medication arms only: Meets standard of care program enrollment criteria for GLP-1 medication. Did not add other products or programs to Noom subscription. * Noom Weight only: Individual who is not interested in medication * Education-only Control Group: Individual who is interested in weight loss who is not currently enrolled in a structured weight loss program or medication program and does not intend to for the duration of the study Free Tier only: Willingness to use Free Tier Exclusion Criteria: * Study screener completed more than 11 days after Noom program enrollment if participating in a Noom program (GLP-1 programs, Noom Weight, and Free Tier) * GLP-1 use in the last 24 weeks (prior to Noom program enrollment if in GLP-1 arm) * Female who is pregnant, breast-feeding, or intends to become pregnant during the 12-month program * Previous or planned (during the 12-month study) bariatric surgery * Active eating disorder * Active cancer * Type 1 diabetes or current Insulin use * Currently taking a medication known to cause weight gain (e.g., antipsychotics, antidepressants, diabetes medication, or corticosteroids) * Depression screen results in a PHQ-8 score of 20 or greater. All medicated arms and Noom Weight arms (only): \- Purchased more than the base Noom program offered for participant's specific arm GLP-1 Medication Arms Only: * GLP-1 agonist use is contraindicated (per program criteria) in members with: * Personal or family history of medullary thyroid cancer * Personal or family history of Multiple Endocrine Neoplasia Type 2 (MEN2) * Personal history of Pancreatitis

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Conditions

The condition(s) this trial relates to.

Body Weight Obesity obesity disorder Overweight Weight Loss

As listed by the trial registrant

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

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

  • Noom, Inc.

    Princeton, New Jersey, 08542, United States

More trials for these conditions

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