A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (AURORA-1)
Status: Recruiting
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Study ASC30-301 (AURORA-1) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight without T2DM.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
• Have a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
‣ Hypertension
⁃ Dyslipidemia
⁃ Obstructive sleep apnea
⁃ Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Locations
United States
Alabama
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Birmingham
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Huntsville
Arkansas
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Little Rock
Arizona
AURORA-1 Clinical Site
RECRUITING
Phoenix
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Tempe
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Tucson
California
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Banning
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Chula Vista
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Covina
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Gardena
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Tarzana
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Tustin
Washington, D.c.
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Washington D.c.
Florida
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Boca Raton
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Daytona Beach
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Jacksonville
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Leesburg
AURORA-1 Clinical Site
RECRUITING
Melbourne
AURORA-1 Clinical Site
NOT_YET_RECRUITING
South Miami
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Tampa
AURORA-1 Clinical Site
RECRUITING
The Villages
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Winter Park
Georgia
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Canton
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Decatur
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Union City
Idaho
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Boise
Illinois
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Schaumburg
Indiana
AURORA-1 Clinical Site
RECRUITING
Evansville
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Indianapolis
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Valparaiso
Kansas
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Kansas City
Maryland
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Bowie
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Rockville
Missouri
AURORA-1 Clinical Site
NOT_YET_RECRUITING
St Louis
Mississippi
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Jackson
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Olive Branch
North Carolina
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Charlotte
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Greenville
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Morehead City
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Raleigh
Nevada
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Las Vegas
New York
AURORA-1 Clinical Site
NOT_YET_RECRUITING
New Windsor
Ohio
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Cincinnati
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Cleveland
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Columbus
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Dayton
Oregon
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Eugene
Pennsylvania
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Philadelphia
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Pittsburgh
South Carolina
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Bluffton
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Clemson
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Columbia
Tennessee
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Memphis
Texas
AURORA-1 Clinical Site
RECRUITING
Austin
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Brownsville
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Desoto
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Frisco
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Houston
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Mesquite
AURORA-1 Clinical Site
NOT_YET_RECRUITING
San Antonio
AURORA-1 Clinical Site
RECRUITING
San Antonio
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Sugar Land
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Tomball
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Weslaco
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Wichita Falls
Utah
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Salt Lake City
Virginia
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Hampton
Other Locations
Canada
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Burlington
Germany
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Berlin
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Berlin
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Essen
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Hanover
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Leipzig
Greece
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Athens
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Athens
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Athens
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Larissa
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Marousi
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Palaió Fáliro
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Pylaia
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Thessaloniki
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Thessaloniki
Poland
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Biała Podlaska
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Bydgoszcz
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Częstochowa
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Gdansk
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Gdynia
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Gdynia
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Katowice
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Krakow
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Krakow
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Lodz
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Lodz
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Lublin
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Lublin
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Poznan
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Poznan
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Puławy
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Siedlce
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Staszów
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Torun
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Warsaw
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Warsaw
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Warsaw
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Warsaw
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Warsaw
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Wroclaw
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Wroclaw
United Kingdom
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Bellshill
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Cardiff
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Edgbaston
AURORA-1 Clinical Site
NOT_YET_RECRUITING
London
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Manchester
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Manchester
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Stoke-on-trent
AURORA-1 Clinical Site
NOT_YET_RECRUITING
Warrington
Time Frame
Start Date:2026-08
Estimated Completion Date:2028-07
Participants
Target number of participants:3003
Treatments
Experimental: ASC30 Cohort 1
Participants will receive oral ASC30 tablets A1.
Experimental: ASC30 Cohort 2
Participants will receive oral ASC30 tablets A1.
Experimental: ASC30 Cohort 3
Participants will receive oral ASC30 tablets A1.
Placebo_comparator: Placebo Cohort 4
Participants will receive matching placebo tablets orally once daily.