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New RNA injection targets obesity and diabetes in early trial

NCT ID NCT06937203

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 09, 2026 · Updated 4 times

Summary

This early-stage study tests an experimental drug called ARO-ALK7 in 138 adults with obesity, some of whom also have type 2 diabetes. The drug is given as an injection and aims to help with weight loss and blood sugar control. The main goal is to check safety and how the body processes the drug, with some participants also receiving a standard diabetes medication (tirzepatide) alongside ARO-ALK7.

What this could mean

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

Active substance
ARO-ALK7 (an experimental RNA-based drug given as an injection)
What this could lead to
If successful, this could point toward a new treatment for obesity and type 2 diabetes that helps with weight loss and blood sugar control.
What could go wrong
This is an early-phase trial (Phase 1/2a) focused on safety and dosing, so it's too soon to know if it works. Side effects are possible, and results may not lead to a final treatment.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

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

Started

May 2025

Expected to finish

Feb 2027

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.

Ages

18 to 65 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: * Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m\^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds \[lbs\]) * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results * Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later Exclusion Criteria: * Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening * Use of glucagon-like peptide-1 receptor agonist (GLP-1RAs) (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening * Use of non-GLP-1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplement taken for weight loss purposes * Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome) * History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures) * Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening * Type 1 diabetes mellitus Note: Additional inclusion/exclusion criteria may apply per protocol.

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Conditions

The condition(s) this trial relates to.

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

    8 sites in 2 countries. 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

  • Research Site 1

    RECRUITING

    Auckland, 1010, New Zealand

  • Research Site 2

    RECRUITING

    Christchurch, 8011, New Zealand

  • Research Site 3

    RECRUITING

    Takapuna, Auckland, 0622, New Zealand

  • Research Site 4

    RECRUITING

    Rotorua, 3010, New Zealand

  • Research Site 5

    RECRUITING

    Grafton, Auckland, 1010, New Zealand

  • Research Site 6

    RECRUITING

    Papatoetoe, Auckland, 2025, New Zealand

  • Research Site 7

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Research Site 8

    RECRUITING

    Morayfield, QLC, 4506, Australia

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