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A Study of DA-302168S in Participants With Overweight/Obesity

ConditionOverweight and Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChendu DIAO Pharmaceutical Group CO., LTD.

About this trial

This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aimed at evaluating the efficacy, safety, and pharmacokinetic (PK) characteristics of DA-302168S tablets in overweight or obese participants in China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years (inclusive), both males and females;

BMI requirements at screening: for obese participants, BMI ≥28 kg/m² with or without comorbidities; or for overweight participants, BMI ≥24.0 kg/m² and <28 kg/m² with at least one of the following comorbidities: hypertension, prediabetes, dyslipidemia, weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases), obstructive sleep apnea syndrome, or metabolic dysfunction-associated steatotic liver disease;

Body weight change <5% (based on participant self-report, calculated as [maximum weight - minimum weight] / maximum weight, with the result rounded to one significant digit) during the 3 months prior to screening, while on diet and exercise control (based on participant self-report).

Disqualifiers

Type 1 diabetes, type 2 diabetes, or other specific types of diabetes (excluding gestational diabetes);

Secondary obesity, history of bariatric surgery;

Presence of gastrointestinal diseases affecting drug absorption, dysphagia;

Personal/family history of medullary thyroid carcinoma, C-cell hyperplasia, or multiple endocrine neoplasia type 2; uncontrolled hyperthyroidism or hypothyroidism without standard stable management; thyroid nodule with TI-RADS grade 4 or above;

Trial design

Design model

Parallel

Treatments tested in this trial

  • DA-302168S

    Drug

    A small molecule GLP-1R agonist tablet, orally administration, once daily

  • DA-302168S

    Drug

    A small molecule GLP-1R agonist tablet, orally administration, once daily

  • Placebo

    Drug

    Matching placebo tablet will be provided

Treatment groups

840 Participants
are divided into 3 treatment groups
Group A: High dose groupActive comparator 1 intervention
Group B: Low dose groupActive comparator 1 intervention
Group C: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change from baseline in body weight

Time frame
From baseline to week 40
2

The proportion of subjects with a body weight reduction ≥5% from baseline

Time frame
From baseline to week 40

Secondary outcomes

1

The proportion of subjects with a body weight reduction of ≥10% and ≥15%

Time frame
From baseline to week 40
2

Percentage change from baseline in body weight

Time frame
From baseline to week 52
3

The proportion of subjects with a body weight reduction ≥5%、10%、15% from baseline

Time frame
From baseline to week 52
4

Changes from baseline in hip circumference

Time frame
From baseline to week 40 and week 52

Other outcomes

Sponsors and contacts

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

Chendu DIAO Pharmaceutical Group CO., LTD.

Lead sponsor

Peking University People's Hospital

Collaborator

Source ClinicalTrials.gov
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