Clinical trial

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

Recruiting now · Phase 3 · 4 countries · Registry ID NCT07667803

Recruiting nowPhase 3Interventional

What this study is about

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionWeight Management

Full registry criteria

Inclusion Criteria * Legal age of consent and at least 18 years old * Study 1 - * BMI ≥ 30 kg/m2 or * 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities: * Hypertension * Prediabetes * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea. * Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below: * Established diagnosis of T2DM * Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit * Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change) * History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria * Study 1 - Established diagnosis of T1DM or T2DM. * Study 2 - 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

Treatments and study arms

Elecoglipron

Drug

Elecoglipron film-coated tablet once daily

Placebo

Drug

Placebo matching elecoglipron film-coated tablet once daily

Primary outcomes

Percent body weight loss72 weeks

Percent change from baseline to Week 72 in body weight

Study locations

321 locations were listed when this page was built. The first 40 are shown.

Research Site🇦🇷 Buenos Aires, Argentina
Research Site🇦🇷 Buenos Aires, Argentina
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 Caba, Argentina
Research Site🇦🇷 Capital Federal, Argentina
Research Site🇦🇷 Granadero Baigorria, Argentina
Research Site🇦🇷 Lanus, Argentina
Research Site🇦🇷 Rosario, Argentina
Research Site🇦🇷 Rosario, Argentina
Research Site🇦🇷 San Nicolás, Argentina
Research Site🇦🇷 San Vicente, Argentina
Research Site🇦🇺 Botany, Australia
Research Site🇦🇺 Camberwell, Australia
Research Site🇦🇺 Kotara, Australia
Research Site🇦🇺 Maroubra, Australia
Research Site🇦🇺 St Albans, Australia
Research Site🇦🇺 St Leonards, Australia
Research Site🇧🇷 Belém, Brazil
Research Site🇧🇷 Brasília, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 Curitiba, Brazil
Research Site🇧🇷 Fortaleza, Brazil
Research Site🇧🇷 Porto Alegre, Brazil
Research Site🇧🇷 São José dos Campos, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🇨🇦 Brampton, Ontario, Canada
Research Site🇨🇦 Calgary, Alberta, Canada
Research Site🇨🇦 Calgary, Alberta, Canada
Research Site🇨🇦 Hamilton, Ontario, Canada
Research Site🇨🇦 Joliette, Quebec, Canada
Research Site🇨🇦 Moncton, New Brunswick, Canada
Research Site🇨🇦 Montreal, Quebec, Canada
Research Site🇨🇦 Niagara Falls, Ontario, Canada
Research Site🇨🇦 North York, Ontario, Canada
Research Site🇨🇦 Saint-Lambert, Quebec, Canada
Research Site🇨🇦 Sarnia, Ontario, Canada