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A Study of IBI3046 in Participants With Overweight or Obesity

ConditionObesity and Overweight
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female;

2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²;

3.Body weight change ≤ 5 % within 3 months prior to screening ;

4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration;

Disqualifiers

1. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases.

2. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening.

3. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening.

4. Positive screening results for infectious pathogen markers.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI3046

    Drug

    subcutaneous injection

  • placebo

    Drug

    subcutaneous injection

Treatment groups

128 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part1-SAD Placebo Control GroupPlacebo comparator 1 intervention
Group B: Part3-Combination Background Drug + IBI3046 GroupExperimental treatment 1 intervention
Group C: Part4-Combination: Continuous Reference Drug with Intermittent Placebo Control GroupPlacebo comparator 1 intervention
Group D: Part4-Combination: Continuous Reference Drug with Intermittent IBI3046 Treatment GroupExperimental treatment 1 intervention
Group E: Part3-Combination: Reference Drug followed by Placebo Control GroupPlacebo comparator 1 intervention
Group F: Part2-MAD Placebo Control GroupPlacebo comparator 1 intervention
Group G: Part2-MAD IBI3046 Treatment GroupExperimental treatment 1 intervention
Group H: Part1-SAD IBI3046 Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Event

Time frame
up to Day 169 for SAD;up to Day 225 for MAD
2

Change in systolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)

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
3

Change in diastolic blood pressure after dosing in each dose group(Unit of Measure: mmHg)

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
4

Number of participants with clinically significant abnormal findings in complete physical examination(Unit of Measure: participants)

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

Secondary outcomes

1

renal clearance (CLr)

Time frame
up to Day 3 for SAD;up to Day 57 for MAD
2

Immunogenicity characteristics of IBI3046

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
3

Pharmacodynamics (PD) Body weight: change from baseline in body weight. baseline in body weight.

Time frame
up to Day 169 for SAD;up to Day 225 for MAD
4

Area Under the Curve (AUC) of the serum concentration-time profile

Time frame
up to Day 3 for SAD;up to Day 57 for MAD

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: