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Recruiting Phase 3

A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus

NCT07775404 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-08-21
Last updated
2026-10-01

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Elecoglipron →Placebo

Elecoglipron: Elecoglipron film coated tablet once daily

Placebo: Placebo matching elecoglipron film-coated tablet once daily

Study summary

The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult participant aged 18 years or older at the time of informed consent. * Body mass index (BMI) at screening of: * 28 kg/m\^2 or higher, or * 24 kg/m\^2 to less than 28 kg/m\^2 with at least 1 weight-related comorbidity. * Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change) * History of at least 1 self-reported unsuccessful dietary effort to lose body weight. * Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening. Exclusion Criteria: * Any of the following medical history, laboratory values, or complications related to diabetes: * T1DM * HbA1c ≥ 10% (86 mmol/mol) at the screening visit * Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema. * Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis. * History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2.

Primary outcome measure(s)

  • Percent change from baseline to Week 52 in body weight — Week 52
    Percent change from baseline to Week 52 in body weight.
  • Participants achieving at least 5% body weight loss at Week 52 — Week 52
    Achieved at least 5% body weight loss from baseline at Week 52.

Trial sites (49)

FacilityCityRegionStatus
Research Site Baotou China Not Yet Recruiting
Research Site Beijing China Recruiting
Research Site Beijing China Recruiting
Research Site Beijing China Not Yet Recruiting
Research Site Changde China Recruiting
Research Site Changsha China Recruiting
Research Site Changzhou China Recruiting
Research Site Chengdu China Recruiting
Research Site Hefei China Recruiting
Research Site Huangshi China Recruiting
Research Site Jincheng China Recruiting
Research Site Jinzhou Shi China Not Yet Recruiting
Research Site Langfang China Recruiting
Research Site Luoyang China Not Yet Recruiting
Research Site Meihekou China Recruiting
Research Site Nanjing China Not Yet Recruiting
Research Site Nanyang China Recruiting
Research Site Nanyang China Recruiting
Research Site Shanghai China Recruiting
Research Site Shantou China Recruiting
Research Site Shenyang China Recruiting
Research Site Shenyang China Recruiting
Research Site Shijiazhuang China Recruiting
Research Site Wuhan China Withdrawn
Research Site Wuhu China Recruiting
Research Site Xianyang China Recruiting
Research Site Xuzhou China Not Yet Recruiting
Research Site Yan’an China Recruiting
Research Site Yueyang China Recruiting
Research Site Zhumadian China Recruiting
Research Site Zibo China Recruiting
Research Site Hong Kong Hong Kong Recruiting
Research Site Shatin, Hong Kong Hong Kong Not Yet Recruiting
Research Site Alor Star Malaysia Recruiting
Research Site Kuala Lumpur Malaysia Not Yet Recruiting
Research Site Kuching Malaysia Recruiting
Research Site Putrajaya Malaysia Not Yet Recruiting
Research Site Sarawak Miri Malaysia Not Yet Recruiting
Research Site Seremban Malaysia Not Yet Recruiting
Research Site Seri Manjung Malaysia Recruiting

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07775404 on ClinicalTrials.gov ↗ ← All trials in China