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)
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: t
View:
• 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
Locations
United States
Alabama
ACCOMPLISH-2 Research Site
RECRUITING
Birmingham
Arkansas
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Little Rock
Arizona
ACCOMPLISH-2 Research Site
RECRUITING
Chandler
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Phoenix
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Sun City West
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Tucson
California
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Escondido
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Fountain Valley
ACCOMPLISH-2 Research Site
RECRUITING
La Jolla
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Lake Forest
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Rolling Hills Estates
ACCOMPLISH-2 Research Site
RECRUITING
San Diego
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Tustin
Connecticut
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Waterbury
Florida
ACCOMPLISH-2 Research Site
RECRUITING
Clearwater
ACCOMPLISH-2 Research Site
RECRUITING
Fort Myers
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Jacksonville
ACCOMPLISH-2 Research Site
RECRUITING
Leesburg
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Miami
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Ocala
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Ocoee
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Pembroke Pines
Georgia
ACCOMPLISH-2 Research Site
RECRUITING
Atlanta
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Columbus
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Lawrenceville
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Union City
ACCOMPLISH-2 Research Site
RECRUITING
Woodstock
Iowa
ACCOMPLISH-2 Research Site
RECRUITING
Des Moines
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Iowa City
Idaho
ACCOMPLISH-2 Research Site
RECRUITING
Meridian
Kansas
ACCOMPLISH-2 Research Site
RECRUITING
Wichita
Massachusetts
ACCOMPLISH-2 Research Site
RECRUITING
Methuen
Maryland
ACCOMPLISH-2 Research Site
RECRUITING
Silver Spring
Minnesota
ACCOMPLISH-2 Research Site
RECRUITING
Mankato
ACCOMPLISH-2 Research Site
RECRUITING
Minneapolis
Missouri
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Chesterfield
ACCOMPLISH-2 Research Site
RECRUITING
City Of Saint Peters
ACCOMPLISH-2 Research Site
RECRUITING
Hazelwood
ACCOMPLISH-2 Research Site
RECRUITING
Springfield
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
St Louis
Mississippi
ACCOMPLISH-2 Research Site
RECRUITING
Gulfport
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Ridgeland
Montana
ACCOMPLISH-2 Research Site
RECRUITING
Missoula
North Carolina
ACCOMPLISH-2 Research Site
RECRUITING
Charlotte
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Durham
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Fayetteville
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Morehead City
ACCOMPLISH-2 Research Site
RECRUITING
Winston-salem
Nebraska
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Omaha
Nevada
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Las Vegas
New York
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Albany
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Albany
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Brooklyn
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
The Bronx
Ohio
ACCOMPLISH-2 Research Site
RECRUITING
Columbus
Oklahoma
ACCOMPLISH-2 Research Site
RECRUITING
Moore
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Tulsa
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Yukon
Oregon
ACCOMPLISH-2 Research Site
RECRUITING
Portland
Pennsylvania
ACCOMPLISH-2 Research Site
RECRUITING
Philadelphia
South Carolina
ACCOMPLISH-2 Research Site
RECRUITING
Greer
Tennessee
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Nashville
Texas
ACCOMPLISH-2 Research Site
RECRUITING
Austin
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Farmers Branch
ACCOMPLISH-2 Research Site
RECRUITING
Houston
ACCOMPLISH-2 Research Site
RECRUITING
Houston
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
San Antonio
ACCOMPLISH-2 Research Site
RECRUITING
San Antonio
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Wylie
Utah
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Salt Lake City
Virginia
ACCOMPLISH-2 Research Site
NOT_YET_RECRUITING
Burke
ACCOMPLISH-2 Research Site
RECRUITING
Manassas
ACCOMPLISH-2 Research Site
RECRUITING
Suffolk
Washington
ACCOMPLISH-2 Research Site
RECRUITING
Renton
Contact Information
Primary
Medical Director
GSBRClinicalTrials@structuretx.com
1-650-457-1959
Time Frame
Start Date: 2026-07-17
Estimated Completion Date: 2028-11
Participants
Target number of participants: 1100
Treatments
Experimental: aleniglipron Arm 1
Participants will receive aleniglipron administered orally.
Experimental: aleniglipron Arm 2
Participants will receive aleniglipron administered orally.
Experimental: aleniglipron Arm 3
Participants will receive aleniglipron administered orally.
Placebo_comparator: Placebo Arm 4
Participants will receive placebo administered orally.
Related Therapeutic Areas
Sponsors
Leads: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics