Printed from Voxsanity (voxsanity.com.au) — NCT07284901 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
People who have been diagnosed with type 2 diabetes.
People who have been on a stable diabetes treatment plan for at least 3 months before the screening visit — this includes diet and exercise alone, or certain diabetes medications (note: some specific diabetes drug types are not permitted; see exclusion criteria below).
People with a BMI of 27 or higher.
People who have made at least one attempt to lose weight through diet and exercise in the past 6 months without success, by their own account.
Who may not be able to join:
People who have been diagnosed with type 1 diabetes, or any other form of diabetes other than type 2.
People who have experienced a serious diabetes-related emergency called diabetic ketoacidosis or a hyperosmolar state/coma within the past year.
People who have had a severe low blood sugar episode, or who are unaware when their blood sugar drops dangerously low, within the past year.
People who started taking medications within the past 3 months that are known to cause significant weight gain, such as certain antidepressants, antipsychotics, or mood stabilisers.
People whose body weight has changed by more than 5% in the 3 months before screening, by their own account.
People with a personal or family history of a condition called multiple endocrine neoplasia type 2, or a type of thyroid cancer called medullary thyroid cancer.
People with uncontrolled high blood pressure or an unstable heart or blood vessel condition.
People with a history of pancreas inflammation (pancreatitis), whether long-term or acute.
People with a known significant problem with how their stomach empties food, or who have been taking medications that affect gut movement for more than 30 days continuously within the past 3 months.
People who have previously attempted suicide.
People with a significant or unstable major depressive disorder or other severe psychiatric condition within the past 2 years.
People who have used certain diabetes or weight-loss medications — including semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP agonists, glucagon receptor agonists, or other weight-loss treatments — within the 3 months before screening. (Confirm specific medications with the trial site if unsure.)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Kailera Clinical Site, Bruce, Australian Capital Territory
Kailera Clinical Site, Blacktown, New South Wales
Kailera Clinical Site, Kanwal, New South Wales
Kailera Clinical Site, Leichhardt, New South Wales
Kailera Clinical Site, Sydney, New South Wales
Kailera Clinical Site, Sydney, New South Wales
Kailera Clinical Site, Wollongong, New South Wales
Kailera Clinical Site, Herston, Queensland
Kailera Clinical Site, Camberwell, Victoria
Kailera Clinical Site, Melbourne, Victoria
Kailera Clinical Site, South Brisbane,
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT07284901
Sponsor: Kailera
Phase: Phase 3
Status: Recruiting
Condition: Obesity
Trial contact: 781-317-0291
More information: https://clinicaltrials.gov/study/NCT07284901
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
People who have been diagnosed with type 2 diabetes.
People who have been on a stable diabetes treatment plan for at least 3 months before the screening visit — this includes diet and exercise alone, or certain diabetes medications (note: some specific diabetes drug types are not permitted; see exclusion criteria below).
People with a BMI of 27 or higher.
People who have made at least one attempt to lose weight through diet and exercise in the past 6 months without success, by their own account.
Who may not be able to join:
People who have been diagnosed with type 1 diabetes, or any other form of diabetes other than type 2.
People who have experienced a serious diabetes-related emergency called diabetic ketoacidosis or a hyperosmolar state/coma within the past year.
People who have had a severe low blood sugar episode, or who are unaware when their blood sugar drops dangerously low, within the past year.
People who started taking medications within the past 3 months that are known to cause significant weight gain, such as certain antidepressants, antipsychotics, or mood stabilisers.
People whose body weight has changed by more than 5% in the 3 months before screening, by their own account.
People with a personal or family history of a condition called multiple endocrine neoplasia type 2, or a type of thyroid cancer called medullary thyroid cancer.
People with uncontrolled high blood pressure or an unstable heart or blood vessel condition.
People with a history of pancreas inflammation (pancreatitis), whether long-term or acute.
People with a known significant problem with how their stomach empties food, or who have been taking medications that affect gut movement for more than 30 days continuously within the past 3 months.
People who have previously attempted suicide.
People with a significant or unstable major depressive disorder or other severe psychiatric condition within the past 2 years.
People who have used certain diabetes or weight-loss medications — including semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP agonists, glucagon receptor agonists, or other weight-loss treatments — within the 3 months before screening. (Confirm specific medications with the trial site if unsure.)
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 13 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Kailera
Registry
ClinicalTrials.gov
Start date
12 January 2026
Est. completion
27 March 2028
Where this trial is recruiting
🇦🇷 Argentina
🇦🇺 Australia
🇳🇿 New Zealand
🇺🇸 United States
11 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76; Doses 3 and 4 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.