3 registrations that name lixisenatide as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 3 registrations
Status
All 3 registrations
RecruitingNCT07307235
Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents
Phase 4
Shanghai Zhongshan Hospital
About 1,316 people
Started Dec 13, 2025
In plain words A Phase 4 study of lixisenatide in people 18 and older, run by Shanghai Zhongshan Hospital. It plans to enroll about 1,316 people at 24 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Type 2 Diabetes.
Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
Type 2 diabetes mellitus diagnosis.
Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
HbA1c 7.5-11%
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
iGlarLixi (insulin glargine/lixisenatide); standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)
Registered summary
This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. The full summary is on the listing.
Where, as registered
No US site; China (24).
RecruitingNCT06671587
iGlarLixi CGM Study in Chinese T2D Individuals After OADs
Phase 4
Sanofi
About 678 people
Started Dec 10, 2024
In plain words A Phase 4 study of lixisenatide in people 18 and older, run by Sanofi. It plans to enroll about 678 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Type 2 Diabetes (T2D).
Participants who are diagnosed as T2D of at least 1 year before screening visit
Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD
Inadequate control
Body mass index (BMI) within the range 20-40 kg/m2 (inclusive)
3 more inclusion criteria and the exclusion criteria are on the listing.
This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The full summary is on the listing.
Where, as registered
No US site; China (1).
Not yet recruitingNCT07173712
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
Phase 4
Yanbing Li
About 324 people
Starts Mar 15, 2026 (estimated)
In plain words A Phase 4 study of lixisenatide in people 18 to 70, run by Yanbing Li. It plans to enroll about 324 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 70. Conditions: Type 2 Diabetes.
Diagnosed with type 2 diabetes mellitus (T2DM) with a disease duration of >1 year and <15 years.
On a stable dose of at least one oral antidiabetic drug (OAD) for ≥3 months.
HbA1c at screening: >8.0% if on a single OAD; >7.5% if on more than one OAD (centralized laboratory testing, or results from medical centers participating in the National Glycohemoglobin Standardization Program).
Age 18-70 years.
4 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
CSII; Insulin glargine /lixisenatide Fixed Ratio Combination; Insulin Degludec and Insulin Aspart Injection; Insulin Glargine (HOE901 - U300); Metformin
Registered summary
Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. The full summary is on the listing.