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New treatment option for Obesity
Official title A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT06937203
What this study is testing
What is ARO-ALK7?
ARO-ALK7 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
- Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of...
You likely can't join if
- 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...
- Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary...
- 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...
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Morayfield, QLC, Australia
- Nedlands, Western Australia, Australia
- Grafton, Auckland, New Zealand
- Papatoetoe, Auckland, New Zealand
- Takapuna, Auckland, New Zealand
- Auckland, New Zealand
- Christchurch, New Zealand
- Rotorua, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morayfield, QLC, Australia; Nedlands, Western Australia, Australia; Grafton, Auckland, New Zealand; Papatoetoe, Auckland, New Zealand; Takapuna, Auckland, New Zealand; Auckland, New Zealand and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.