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ObesityPhase 3NCT07654361

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

A Phase 3 study testing Aleniglipron in people with Obesity and Overweight, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 71 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Obesity, Overweight, Chronic Weight Management
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
3,600 participants
Where
71 sitesUnited States
Study dates
13 Jul 2026to Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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
  • BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

Who cannot join

  • Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
  • Self-reported change in body weight >5 kg within 3 months before Screening.
  • Have prior or planned surgical or non-surgical treatment for obesity.
  • Have or plan to have endoscopic and/or device-based therapy for obesity.
  • Have obesity induced by other endocrine disorders.
  • Impaired renal function at Screening
  • Chronic malabsorption

Trial locations and contacts

71 sites in 1 country. Contact the study team or a site near you to ask about taking part.

71 sites in 1 country

United States71 sites, 71 recruiting
  • ACCOMPLISH-1 Research Site

    Albany, New York, 12208-3473

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Ann Arbor, Michigan, 48105-1912

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Austin, Texas, 78704

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Austin, Texas, 78731

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Baton Rouge, Louisiana, 70808

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Birmingham, Alabama, 35242

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Birmingham, Alabama, 35294-3360

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Brooklyn, New York, 11220

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Buford, Georgia, 30046

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Butte, Montana, 59701

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Charlotte, North Carolina, 28210

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Chesterfield, Missouri, 63005

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Chicago, Illinois, 60637

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Clearwater, Florida, 33756

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Columbus, Georgia, 31904

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Columbus, Ohio, 43213

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Columbus, Ohio, 43215

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Denison, Texas, 75020-4582

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Durham, North Carolina, 27710-3000

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Escondido, California, 92025

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Fayetteville, North Carolina, 28304

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Gardena, California, 92708

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Greer, South Carolina, 29651

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Gulfport, Mississippi, 39503

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Hazelwood, Missouri, 63042

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Honolulu, Hawaii, 96814-4526

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Houston, Texas, 77040

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Houston, Texas, 77054

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Iowa City, Iowa, 52242

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Knoxville, Tennessee, 37920

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    La Jolla, California, 92108

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Las Vegas, Nevada, 89128

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Lawrenceville, Georgia, 30046

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Leesburg, Florida, 34748

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Louisville, Kentucky, 40213

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Mankato, Minnesota, 56001

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Meridian, Idaho, 83646

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Methuen, Massachusetts, 01844

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Miami, Florida, 33136

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Missoula, Montana, 59804

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Modesto, California, 95355

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Moore, Oklahoma, 73160

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Needham, Massachusetts, 02492

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    New Bern, North Carolina, 28562

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Ocala, Florida, 34470

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Ocoee, Florida, 34761

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Omaha, Nebraska, 68198-7400

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Pembroke, Florida, 33027

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Philadelphia, Pennsylvania, 19152

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Phoenix, Arizona, 85225

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Portland, Oregon, 97202

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Renton, Washington, 98057

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Rexburg, Idaho, 83440

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Richfield, Minnesota, 55423

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Ridgeland, Mississippi, 39157

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Rolling Hills Estates, California, 90274

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    San Antonio, Texas, 78231

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    San Diego, California, 92123

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Sandy City, Utah, 84094

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Silver Spring, Maryland, 20901-4402

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    St Louis, Missouri, 63303-3041

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    St. George, Utah, 84790

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Sun City West, Arizona, 85375

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Tampa, Florida, 33617

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Tucson, Arizona, 85741

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Union City, Georgia, 30291

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Wichita, Kansas, 67218

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Wilmington, North Carolina, 28401

    Medical Director, GSBRClinicalTrials@structuretx.com

    Recruiting
  • ACCOMPLISH-1 Research Site

    Winston-Salem, North Carolina, 27104

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Woodstock, Georgia, 30189

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting
  • ACCOMPLISH-1 Research Site

    Wylie, Texas, 75098

    Medical Director, GSBRClinicalTrials@structuretx.com

    Not yet recruiting

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Being tested
Aleniglipron, Placebo
Keywords
Obesity, Overweight, GSBR-1290, Aleniglipron, Chronic weight management, Obese, Small molecule, GLP-1, 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.

  • AleniglipronDrug

    Drug: aleniglipron administered orally Drug

  • PlaceboDrug

    Drug: placebo administered orally

Study groups in NCT07654361
Study groupRoleWhat they receive
aleniglipron Arm 1ExperimentalParticipants will receive aleniglipron administered orally.
Receives: Drug: Aleniglipron
aleniglipron Arm 2ExperimentalParticipants will receive aleniglipron administered orally.
Receives: Drug: Aleniglipron
aleniglipron Arm 3ExperimentalParticipants will receive aleniglipron administered orally.
Receives: Drug: Aleniglipron
Placebo Arm 4ExperimentalParticipants will receive placebo administered orally.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in body weight from Baseline

    Measured: Baseline and Week 76

Secondary outcomes (14)
  1. Change in body weight (absolute) from Baseline

    Measured: Baseline and week 76

  2. Percentage of participants who achieve ≥5% reduction in body weight

    Measured: Baseline and week 76

  3. Percentage of participants who achieve ≥10% reduction in body weight

    Measured: Baseline and week 76

  4. Percentage of participants who achieve ≥15% reduction in body weight

    Measured: Baseline and week 76

  5. Percentage of participants who achieve ≥20% reduction in body weight

    Measured: Baseline and week 76

  6. Change in waist circumference from Baseline

    Measured: Baseline and week 76

  7. Change in resting systolic blood pressure from Baseline

    Measured: Baseline and week 76

  8. Percent change in fasting triglycerides and non-HDL cholesterol from Baseline

    Measured: Baseline and week 76

  9. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline

    Measured: Baseline and week 76

  10. Change in HbA1c from Baseline

    Measured: Baseline and week 76

  11. Change in body mass index from Baseline

    Measured: Baseline and week 76

  12. Percent change in fasting total cholesterol from Baseline

    Measured: Baseline and week 76

  13. Change in fasting glucose from Baseline

    Measured: Baseline and week 76

  14. Change in resting diastolic blood pressure from Baseline

    Measured: Baseline and week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start13 Jul 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654361
Sponsor's protocol ID
GSBR-1290-12
Status last verified
Jun 2026
First submitted
12 Jun 2026
Last updated
10 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aleniglipron in people with Obesity and Overweight, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 71 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Director (1-650-457-1959, GSBRClinicalTrials@structuretx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in body weight from Baseline (time frame: Baseline and Week 76). 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 10 Aug 2026.

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Clinical Trial NCT07654361 | AzTrials