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NCT06951945CompletedPhase 1

Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity

Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity: A Randomized, Bouble-Blind, Placebo-Controlled Phase Ib Trial

Source: ClinicalTrials.gov · Last updated 30 Apr 2025

Brief summary (registry, in English)

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with obesity. This study includes three multiple-ascending dose cohorts.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
36 (actual)
First submitted
23 Apr 2025
Start date
18 Jul 2024
Primary completion date
23 Dec 2024
Lead sponsor
Tonghua Dongbao Pharmaceutical Co.,Ltd
Diseases
Obesity
NCT number
NCT06951945

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 36
  • From 18 Jul 2024 to the primary completion date, 23 Dec 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Type 1 diabetes, type 2 diabetes, gestational diabetes, or other types of diabetes;
  • History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);
  • Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;

Lab values

  • Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, \>470 ms for females), PR interval \>200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).

Who the study is looking for

  • Age between 18 and 65 years (inclusive), male or female;
  • Body mass index (BMI) ≥ 28 kg/m²;
  • Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Bengbu Medical University
Coordinator of this site? Confirm its status
AnhuiChinaUnknown status
Hangzhou First People's Hospital
Coordinator of this site? Confirm its status
ZhejiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.