ObesityPhase 3NCT07654374

A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

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 74 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

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
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: 1,100 participants
Where: 74 sitesUnited States
Study dates: 17 Jul 2026to Nov 2028
Phase: Phase 3

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Signed Informed Consent
Have a BMI ≥27.0 kg/m2 at Screening
Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening

Who cannot join

Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
Self-reported change in body weight >5 kg (11 pounds) within 3 months before Screening.
Have prior or planned surgical or non-surgical treatment for obesity.

Trial locations and contacts

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

Medical Director contact

1-650-457-1959

GSBRClinicalTrials@structuretx.com

City, postcode or hospital

Sites recruiting now only

74 sites in 1 country

United States74 sites, 74 recruiting

ACCOMPLISH-2 Research Site
Albany, New York, 12206
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Albany, New York, 12208
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Atlanta, Georgia, 30329
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Austin, Texas, 78704
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Birmingham, Alabama, 35242
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Brooklyn, New York, 11220
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Burke, Virginia, 22015
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Chandler, Arizona, 85225
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Charlotte, North Carolina, 28210
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Chesterfield, Missouri, 63005
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
City of Saint Peters, Missouri, 63303
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Clearwater, Florida, 33756
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Columbus, Georgia, 31904
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Columbus, Ohio, 43213
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Des Moines, Iowa, 50314
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Durham, North Carolina, 27710
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Escondido, California, 92025
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Farmers Branch, Texas, 75234
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Fayetteville, North Carolina, 28304
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Fort Myers, Florida, 33912
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Fountain Valley, California, 92708
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Greer, South Carolina, 29651
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Gulfport, Mississippi, 39503
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Hazelwood, Missouri, 63042
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Houston, Texas, 77040
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Houston, Texas, 77054
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Iowa City, Iowa, 52242
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Jacksonville, Florida, 32216
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
La Jolla, California, 92123
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Lake Forest, California, 92630
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Las Vegas, Nevada, 89128
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Lawrenceville, Georgia, 30046
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Leesburg, Florida, 34748
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Little Rock, Arkansas, 72211
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Manassas, Virginia, 20110
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Mankato, Minnesota, 56001
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Meridian, Idaho, 83646
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Methuen, Massachusetts, 01844
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Miami, Florida, 33136
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Minneapolis, Minnesota, 55423
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Missoula, Montana, 59804
Medical Director GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Moore, Oklahoma, 73160
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Morehead City, North Carolina, 23730
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Nashville, Tennessee, 37203
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Ocala, Florida, 34470
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Ocoee, Florida, 34761
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Omaha, Nebraska, 68105
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Pembroke Pines, Florida, 33027
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Philadelphia, Pennsylvania, 19152
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Phoenix, Arizona, 85028
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Portland, Oregon, 97202
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Renton, Washington, 98057
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Ridgeland, Mississippi, 39157
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Rolling Hills Estates, California, 90274
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Salt Lake City, Utah, 84107
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
San Antonio, Texas, 78229
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
San Antonio, Texas, 78230
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
San Diego, California, 92108
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Silver Spring, Maryland, 20901
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Springfield, Missouri, 65807
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
St Louis, Missouri, 63141
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Suffolk, Virginia, 23435
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Sun City West, Arizona, 85375
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
The Bronx, New York, 10455
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Tucson, Arizona, 85741
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Tulsa, Oklahoma, 74133
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Tustin, California, 92780
Medical Director, GSBRClinicalTrials@structuretx.com
Not yet recruiting
ACCOMPLISH-2 Research Site
Union City, Georgia, 30291
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Waterbury, Connecticut, 06708
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Wichita, Kansas, 67218
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Winston-Salem, North Carolina, 27104
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Woodstock, Georgia, 30189
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Wylie, Texas, 75098
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting
ACCOMPLISH-2 Research Site
Yukon, Oklahoma, 73099
Medical Director, GSBRClinicalTrials@structuretx.com
Recruiting

Other trials in United States

About this study

Official title: A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

Conditions: Obesity, Overweight, Chronic Weight Management, Type2 Diabetes Mellitus
Being tested: aleniglipron, Placebo
Keywords: obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, type 2diabetes mellitus, 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
aleniglipronDrug
Drug: aleniglipron administered orally
aleniglipronDrug
Drug: aleniglipron administered orally
PlaceboDrug
Drug: placebo administered orally

Study groups in NCT07654374
Study group	Role	What they receive
aleniglipron Arm 1	Experimental	Participants will receive aleniglipron administered orally. Receives: Drug: aleniglipron
aleniglipron Arm 2	Experimental	Participants will receive aleniglipron administered orally. Receives: Drug: aleniglipron
aleniglipron Arm 3	Experimental	Participants will receive aleniglipron administered orally. Receives: Drug: aleniglipron
Placebo Arm 4	Placebo comparator	Participants 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.

Percent change in body weight from Baseline
Measured: Baseline and week 76

Secondary outcomes (9)

Change in body weight (absolute) from Baseline
Measured: Baseline and week 76
Percentage of participants who achieve ≥5% reduction in body weight
Measured: Baseline and week 76
Percentage of participants who achieve ≥10% reduction in body weight
Measured: Baseline and week 76
Percentage of participants who achieve ≥15% reduction in body weight
Measured: Baseline and week 76
Change in waist circumference from Baseline
Measured: Baseline and week 76
Change in HbA1c from Baseline
Measured: Baseline and week 76
Change in resting systolic blood pressure from Baseline
Measured: Baseline and week 76
Percent change in fasting triglycerides and non-HDL cholesterol from Baseline
Measured: Baseline and week 76
Percentage of participants achieving HbA1c target value of ≤6.5%
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.

17 Jul 2026Nov 2028

First posted17 Jun 2026
Study start17 Jul 2026
Primary completionSep 2028 (estimated)
Study completionNov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07654374
Sponsor's protocol ID: GSBR-1290-15
Status last verified: Jun 2026
First submitted: 12 Jun 2026
Last updated: 20 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

Interested in taking part?

Medical Director

1-650-457-1959

GSBRClinicalTrials@structuretx.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruiting
tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity
Obesity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity

All Obesity trials