Obesity, Overweight, or Chronic Weight ManagementPhase 2NCT07169942
Aleniglipron Phase 2 Body Composition Study
A Phase 2 study of Obesity, Overweight, or Chronic Weight Management, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 11 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obesity, Overweight, or Chronic Weight Management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 11 sitesUnited States
- Study dates
- 15 Aug 2025to 10 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
- Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2
- Screening HbA1c <6.5 %
Who cannot join
- Previous documented diagnosis of diabetes mellitus
- Self-reported change in body weight >5% within 3 months before Screening
- Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Research Site
Austin, Texas, 78704
Research Site
Chicago, Illinois, 60602
Research Site
City of Saint Peters, Missouri, 63303
Research Site
Moncks Corner, South Carolina, 29461
Research Site
Norman, Oklahoma, 73069
Research Site
North Charleston, South Carolina, 29405
Research Site
Phoenix, Arizona, 85020
Research Site
Richfield, Minnesota, 55423
Research Site
Rochester, New York, 14609
Research Site
San Antonio, Texas, 78240
Research Site
Wilmington, North Carolina, 28401
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 44 weeks of treatment.
- Being tested
- aleniglipron or placebo
- Keywords
- obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, body composition, Structure Therapeutics
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aleniglipron or placeboDrug
Drug: aleniglipron administered orally Drug: placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive aleniglipron or placebo administered orally. Receives: Drug: aleniglipron or placebo |
| Cohort 2 | Experimental | Participants will receive aleniglipron or placebo administered orally. Receives: Drug: aleniglipron or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total body fat mass by DXA
Measured: Baseline and week 44
Secondary outcomes (4)
Percent change in visceral adipose tissue [VAT] by DXA
Measured: Baseline and week 44
Percent change in lean body mass by DXA
Measured: Baseline and week 44
Percent change in body weight by DXA
Measured: Baseline and week 44
Percent change in waist circumference
Measured: Baseline and week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Aug 2025
- Primary completion9 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Overweight, or Chronic Weight ManagementStudies 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
- 71 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
- NCT07169942
- Sponsor's protocol ID
- GSBR-1290-16
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2025
- Last updated
- 14 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 14 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 Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)
- ClinicalTrials.gov ID
- NCT07169942
- Acronym / sponsor ID
- GSBR-1290-16
- Keywords
- obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, body composition, Structure Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 12 Sep 2025 (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.
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 44 weeks of treatment.
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 |
|---|---|---|
| Cohort 1 | Experimental | Drug: aleniglipron or placeboParticipants will receive aleniglipron or placebo administered orally. |
| Cohort 2 | Experimental | Drug: aleniglipron or placeboParticipants will receive aleniglipron or 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 (3 listed)
- Signed informed consent
- Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2
- Screening HbA1c <6.5 %
Key exclusion criteria (5 listed)
- Previous documented diagnosis of diabetes mellitus
- Self-reported change in body weight >5% within 3 months before Screening
- Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)
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 |
|---|---|---|
| aleniglipron or placeboDrug: aleniglipron administered orally Drug: placebo administered orally | Drug | Cohort 1, Cohort 2 |
Primary outcome
Percent change in total body fat mass by DXA
Time frame: Baseline and week 44
4 secondary outcomes
Percent change in visceral adipose tissue [VAT] by DXA
Time frame: Baseline and week 44
Percent change in lean body mass by DXA
Time frame: Baseline and week 44
Percent change in body weight by DXA
Time frame: Baseline and week 44
Percent change in waist circumference
Time frame: Baseline and week 44
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 14 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
Related trials for Obesity, Overweight, or Chronic Weight Management
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A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
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RecruitingPhase 3
A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
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RecruitingPhase 3
Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Obesity, Overweight, or Chronic Weight Management, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 11 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 3 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 14 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 11 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?
Percent change in total body fat mass by DXA (time frame: Baseline and week 44). 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 14 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.