Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101125, China
NCT Number: NCT07809945
This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 101125, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subcutaneous injection
subcutaneous injection
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Systolic blood pressure will be measured and recorded at each specified time point
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
diastolic blood pressure will be measured and recorded at each specified time point
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
A complete physical examination will be performed at each specified time point, including assessment of general appearance, respiratory system, cardiovascular system, abdomen, skin, head and neck (including ears, nose, and throat), lymph nodes, thyroid gland, musculoskeletal system (including spine and extremities), and neurological system. Any finding that is new or worsened from baseline and deemed clinically significant by the investigator will be
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Abnormal changes in ECG heart rate, rhythm, and morphology of each wave segment will be recorded.
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
To characterize the immunogenicity of IBI3046 based on serum sample analysis at prespecified time points as defined in the study protocol.
Time frame: up to Day 169 for SAD;up to Day 225 for MAD
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Time frame: up to Day 3 for SAD;up to Day 57 for MAD
Contact information is provided by the study sponsor or research team.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Randomized, Double Blind, Placebo Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of IBI3046 in Chinese Participants With Overweight or Obesity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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