UBT251 Injection Phase Ⅲ Study (Overweight or Obesity)
ConditionObesity & Overweight
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.
About this trial
This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
Eligibility criteria
Qualifiers
Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender;
Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI <28.0 kg/m² (overweight) at screening, accompanied by by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome;
Self-reported having been on diet and exercise control for 3 months or more prior to screening, with body weight change ≤5 kg within the past 3 months;
Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion;
Disqualifiers
Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, glucagon-like peptide-1 (GLP-1) analogs, glucose-dependent insulinotropic polypeptide (GIP) analogs, or glucagon (GCG) analogs;
Use of over-the-counter weight-loss medications or appetite suppressants (including traditional Chinese medicine, dietary supplements, meal replacements), or prescription weight-loss medications (including but not limited to orlistat) or lipolytic injections (e.g., fat-dissolving injections);
Use of medications that may affect body weight for a duration of 1 week or longer, or anticipated use during the trial, including but not limited to systemic glucocorticoid therapy (intravenous or oral administration, except for the following: topical external use or intra-articular, intranasal, ophthalmic, and inhaled glucocorticoids; short-term [≤7 days] systemic glucocorticoid use for prevention or treatment of non-autoimmune allergic diseases, upper respiratory tract infection);
Trial design
Treatments tested in this trial
- UBT251 Injection 4.0 mg
- UBT251 Injection 6.0 mg
- UBT251 Injection Placebo 4.0 mg
- UBT251 Injection Placebo 6.0 mg
Treatment groups
600 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov