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

Recruiting · NCT07775404 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed.

Research Site - Alor Star, Malaysia
Research Site - Alor Star, Malaysia
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Baotou, China
Research Site - Baotou, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Changde, China
Research Site - Changde, China
Research Site - Changsha, China
Research Site - Changsha, China
Research Site - Changzhou, China
Research Site - Changzhou, China
Research Site - Chengdu, China
Research Site - Chengdu, China
Research Site - Chiang Mai, Thailand
Research Site - Chiang Mai, Thailand
Research Site - Davao City, Philippines
Research Site - Davao City, Philippines
Research Site - Hefei, China
Research Site - Hefei, China
Research Site - Hong Kong, Hong Kong
Research Site - Hong Kong, Hong Kong
Research Site - Huangshi, China
Research Site - Huangshi, China
Research Site - Iloilo City, Philippines
Research Site - Iloilo City, Philippines
Research Site - Jincheng, China
Research Site - Jincheng, China
Research Site - Jinzhou Shi, China
Research Site - Jinzhou Shi, China
Research Site - Kuala Lumpur, Malaysia
Research Site - Kuala Lumpur, Malaysia
Research Site - Kuching, Malaysia
Research Site - Kuching, Malaysia
Research Site - Langfang, China
Research Site - Langfang, China
Research Site - Luoyang, China
Research Site - Luoyang, China
Research Site - Manila, Philippines
Research Site - Manila, Philippines
Research Site - Meihekou, China
Research Site - Meihekou, China
Research Site - Nanjing, China
Research Site - Nanjing, China
Research Site - Nanyang, China
Research Site - Nanyang, China
Research Site - Nanyang, China
Research Site - Nanyang, China
Research Site - Phutthamonthon, Thailand
Research Site - Phutthamonthon, Thailand
Research Site - Putrajaya, Malaysia
Research Site - Putrajaya, Malaysia

Showing 60 of 98 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →