New diabetes shot every two weeks could rival weekly drug
NCT ID NCT06257966
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 3 trial compares two doses of an experimental drug called JY09 against the approved drug dulaglutide in 600 adults with type 2 diabetes not well controlled by metformin alone. Participants receive either JY09 every two weeks or dulaglutide once a week for 54 weeks. The main goal is to see how well each treatment lowers blood sugar levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JY09 (exendin-4 Fc fusion protein injection)
- What this could lead to
- If it works, JY09 could offer a convenient biweekly injection option to help control blood sugar in people with type 2 diabetes.
- What could go wrong
- This is a phase 3 trial, but JY09 is still experimental. It may not prove better or safer than existing weekly dulaglutide, and side effects are possible.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
600 people
The number who actually took part.
- Started
-
Jul 2024
- Expected to finish
-
Nov 2026
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 75 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 Hide 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: 1. Male or female subjects ≥18 years of age and ≤75 years of age at the time of signing the informed consent form. 2. Those who meet the World Health Organization(WHO)1999 diagnostic criteria for type 2 diabetes mellitus and the WHO Recommendations for the Use of Glycosylated Haemoglobin (HbA1c) for Diagnosis (2011) supplemental diagnostic criteria for a diagnosis of T2DM for ≥ 12 weeks. 3. Received a stable dose of metformin monotherapy with a metformin dose ≥1500 mg/day or a maximally tolerated dose (\<1500 mg/day but ≥1000 mg/day) on the basis of dietary and exercise interventions during the 8 weeks prior to screening. 4. HbA1c ≥7.5% and ≤11.0% at screening (local laboratory) and HbA1c ≥7.0% and ≤10.5% before randomization (V3) (central laboratory). 5. FPG 13.9 mmol/L at screening (local laboratory) and FPG 13.9 mmol/L before randomization (V3) (central laboratory). 6. Body mass index (BMI) ≥18.5 kg/m2 and ≤35.0 kg/m2 at screening and before randomization (V4). 7. Able to understand and willing to sign a written informed consent form (ICF) and comply with the study protocol. Exclusion Criteria: 1. People diagnosed with type 1 diabetes or other types of diabetes. 2. Those who have used glucose-lowering drugs other than metformin within 8 weeks prior to screening or prior to randomization (V4), or those who have used drugs that may affect glucose metabolism, such as systemic glucocorticosteroids (except for inhalation or topical topical use) and growth hormone. 3. Those who have used glucose-dependent insulinotropic polypeptide (GIP) and/or glucagon-like peptide-1 (GLP-1) receptor agonists (including single-target, multi-target agonists, and insulin-containing GLP-1 combinations) within 3 months prior to screening. 4. More than 14 days of continuous insulin use in the 6 months prior to screening. 5. Acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening or prior to randomization . 6. Severe chronic complications of diabetes mellitus (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening, which are assessed by the investigator to be unsuitable for participation in this clinical study. 7. Individuals who have had severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease, etc.) or have undergone gastrointestinal surgery within 6 months prior to screening or prior to randomization or who have been using long-term medications for chronic gastrointestinal disease that have a direct effect on gastrointestinal motility are not suitable for participation in this clinical study, as assessed by the investigator. 8. Other conditions that, in the judgment of the investigator, make the subject unsuitable for participation in this clinical study.
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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.
Contacts and locations
Locations
-
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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