GLP-1 Peptide Atlas, by Delfa

Not yet recruitingPhase 3

BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity

BALANCE-OBS: A Multiregional, Randomized, Multicenter, Active-Controlled Confirmatory Phase III Study to Evaluate the Efficacy and Safety of Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity

Lead sponsor

Carnot Laboratories

Assets

GZR18 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

352

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body Weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07622810

Org study IDPC-ECI-CM-102-2026

Timeline

Milestones

Study first posted2026-06-03actual

Last update posted2026-06-03actual

Study start2026-09estimated (month precision)

Primary completion2027-12estimated (month precision)

Study completion2027-12estimated (month precision)

Assets

Investigational agents

GZR18 Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female participants aged ≥18 years.

•Body mass index (BMI): ≥30.0 kg/m² (obesity), or ≥27.0 kg/m² and <30.0 kg/m² (overweight) with at least one weight-related comorbidity, including impaired glucose metabolism, hypertension, dyslipidemia, metabolic dysfunction-associated steatotic liver disease (MASLD), osteoarthritis attributable to excess weight, or obstructive sleep apnea.

•Body weight managed through diet and exercise alone for at least 12 weeks prior to screening, with <5% change in body weight during the previous 12 weeks.

•Willingness and ability to maintain a stable diet and physical activity regimen throughout the study.

•Female participants of reproductive potential must not be pregnant or breastfeeding, must have a negative pregnancy test at screening and prior to randomization, and must agree to use a highly effective method of contraception during the study and for at least 8 weeks after the last dose of study drug.

•Male participants must agree to use effective contraception and refrain from sperm donation during the study and for at least 8 weeks after the last dose of study drug.

•Ability to understand the study requirements and provide written informed consent prior to any study-specific procedures.

Exclusion criteria

•Known or suspected hypersensitivity to GLP-1 receptor agonists, GLP-1/GIP receptor agonists, or any component of the investigational product.

•History of substance abuse or alcoholism within 6 months prior to screening.

•Presence of conditions that may interfere with accurate anthropometric assessments.

•History of bariatric surgery or planned bariatric surgery during the study.

•Obesity secondary to an underlying disease or medication.

•Previous diagnosis of diabetes mellitus (except gestational diabetes).

•History of severe hypoglycemia within 6 months prior to screening.

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2).

•History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer or carcinoma in situ.

•Clinically significant thyroid disease, pancreatitis, gallbladder disease, gastrointestinal disease, cardiovascular disease, cerebrovascular disease, hepatic disease, renal disease, or hematologic disease that, in the Investigator's judgment, may interfere with study participation.

•Uncontrolled hypertension or clinically significant electrocardiogram abnormalities.

•Moderate or severe psychiatric disorders, clinically significant eating disorders, suicidal ideation or behavior, or a PHQ-9 score ≥15 at screening.

•Clinically significant laboratory abnormalities at screening, including abnormalities in liver function, renal function, pancreatic enzymes, calcitonin, hematology, glycemic parameters, or positive testing for HIV, active hepatitis B, hepatitis C, or syphilis.

•Prior use of GLP-1 receptor agonists, dual/triple incretin agonists, weight-loss medications, hypoglycemic agents, or other medications that may affect body weight within 3 months prior to screening.

•Acute infection requiring systemic treatment at screening or prior to randomization.

•Participation in another interventional clinical trial within 90 days or 5 half-lives of the investigational product (whichever is longer) prior to randomization.

•History of organ transplantation, major surgery, or severe trauma within 6 months prior to screening.

•Any condition that, in the Investigator's judgment, may compromise participant safety, protocol compliance, or the validity of study results.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Other (unclassified)

Weight & body composition

4 endpoints

Primary/protocol endpoint

Percent Change in Body Weight From Baseline to Week 36

Time frame:Baseline to Week 36

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of Participants Achieving Clinically Relevant Weight Reduction

Time frame:Baseline to Week 36

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI) From Baseline at Week 36

Time frame:Baseline to Week 36