ObesePhase 2GSBR-1290NCT07400588
Aleniglipron Phase 2 in Type 2 Diabetes Mellitus
A Phase 2 study testing Aleniglipron in people with Obese and Obesity, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 16 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 180 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obese, Obesity, Obesity Type 2 Diabetes Mellitus
- What is being tested?
- Aleniglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Dec 2025to 18 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- A diagnosis of T2DM of ≥6 months,
- On stable treatment for T2DM for at least 90 days prior to Screening
- Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening
- Have a BMI ≥27.0 kg/m2
Who cannot join
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema.
- Present or planned use of any drug that could interfere with glucose levels
- Self-reported change in body weight >5 kg (11 pounds) within 3 months before screening
- Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to Screening)
- Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Research Site
Anniston, Alabama, 36207
Research Site
Austin, Texas, 78704
Research Site
Chattanooga, Tennessee, 37421
Research Site
Columbus, Ohio, 43212
Research Site
DeSoto, Texas, 75115
Research Site
Hazelwood, Missouri, 63042
Research Site
Houston, Texas, 77079
Research Site
Knoxville, Tennessee, 37909
Research Site
Lake Forest, California, 92630
Research Site
Lomita, California, 90717
Research Site
Mesquite, Texas, 75149
Research Site
Moncks Corner, South Carolina, 29461
Research Site
San Antonio, Texas, 78215
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78240
Research Site
Tomball, Texas, 77375
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety and Tolerability of Aleniglipron in Adult Participants With Type 2 Diabetes Mellitus Living With Obesity or Overweight
The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 180 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).
- Conditions
- Obese, Obesity, Obesity Type 2 Diabetes Mellitus, Weight Loss
- Being tested
- Aleniglipron, Placebo
- Keywords
- Obese, obesity, Obesity Type 2 Diabetes, Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleniglipronDrug
Drug aleniglipron administered orally
PlaceboDrug
Drug placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Participants will receive aleniglipron administered orally | Experimental | Drug aleniglipron administered orally Receives: Drug: Aleniglipron |
| Arm 2: Participants will receive a placebo administered orally | Experimental | Drug placebo administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of AEs/SAEs
Measured: Baseline to week 31
Assessment of vital signs
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Measured: Baseline to week 31
Assessment of laboratory measures
Number of Participants with Abnormal Laboratory Parameters: including hematology, serum chemistry, coagulation
Measured: Baseline to week 31
Assessment of Electrocardiograms (ECG)
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
Measured: Baseline to week 31
Secondary outcomes (8)
Absolute change in body weight from Baseline
Measured: Baseline to week 31
Percent change in body weight from Baseline
Measured: Baseline to week 31
Change in HbA1c from Baseline
Measured: Baseline to week 30
Change in fasting plasma glucose from Baseline
Measured: Baseline to week 31
PK parameters including but not limited to AUC
Measured: Baseline to week 30
PK parameters including but not limited to Cmax
Measured: Baseline to week 30
PK parameters including but not limited to Tmax
Measured: Baseline to week 30
PK parameters including but not limited to Ctrough
Measured: Baseline to week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Dec 2025
- Primary completion18 Sep 2026
- Study completion18 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400588
- Sponsor's protocol ID
- GSBR-1290-17
- Acronym
- GSBR-1290
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety and Tolerability of Aleniglipron in Adult Participants With Type 2 Diabetes Mellitus Living With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT07400588
- Acronym / sponsor ID
- GSBR-1290 / GSBR-1290-17
- Conditions
- Obese, Obesity, Obesity Type 2 Diabetes Mellitus, Weight Loss
- Keywords
- Obese, obesity, Obesity Type 2 Diabetes, Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 180 mg once daily (QD) in participants with T2DM who are living with obesity (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Participants will receive aleniglipron administered orally | Experimental | Drug: AleniglipronDrug aleniglipron administered orally |
| Arm 2: Participants will receive a placebo administered orally | Experimental | Drug: PlaceboDrug placebo administered orally |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- A diagnosis of T2DM of ≥6 months,
- On stable treatment for T2DM for at least 90 days prior to Screening
- Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening
- Have a BMI ≥27.0 kg/m2
Key exclusion criteria (5 listed)
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All participants must have a photo fundoscopy, optical coherence tomography, or slit lamp assessment prior to randomization and within the last 12 months to confirm the absence or stable status of diabetic retinopathy and/or macular edema.
- Present or planned use of any drug that could interfere with glucose levels
- Self-reported change in body weight >5 kg (11 pounds) within 3 months before screening
- Have prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to Screening)
- Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening, including, but not limited to, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal endoluminal liner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AleniglipronDrug aleniglipron administered orally | Drug | Arm 1: Participants will receive aleniglipron administered orally |
| PlaceboDrug placebo administered orally | Drug | Arm 2: Participants will receive a placebo administered orally |
Primary outcome
Incidence, severity and relationship of AEs/SAEs
Time frame: Baseline to week 31
Assessment of vital signs
Time frame: Baseline to week 31
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Assessment of laboratory measures
Time frame: Baseline to week 31
Number of Participants with Abnormal Laboratory Parameters: including hematology, serum chemistry, coagulation
Assessment of Electrocardiograms (ECG)
Time frame: Baseline to week 31
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
8 secondary outcomes
Absolute change in body weight from Baseline
Time frame: Baseline to week 31
Percent change in body weight from Baseline
Time frame: Baseline to week 31
Change in HbA1c from Baseline
Time frame: Baseline to week 30
Change in fasting plasma glucose from Baseline
Time frame: Baseline to week 31
PK parameters including but not limited to AUC
Time frame: Baseline to week 30
PK parameters including but not limited to Cmax
Time frame: Baseline to week 30
PK parameters including but not limited to Tmax
Time frame: Baseline to week 30
PK parameters including but not limited to Ctrough
Time frame: Baseline to week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aleniglipron in people with Obese and Obesity, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and relationship of AEs/SAEs (time frame: Baseline to week 31). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.