> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-master-protocol-to-investigate-efficacy-and-safety-of-c0bbb82c-c9eb-4055-9a98-3f156f850a80 > Record changed: 2026-11-04 # A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM NCT07667803 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) Participants 4,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) Start date 2026-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) Number of sites 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Acronym** Embold Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Short title** A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Official title** A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Dates **Completion date** 2029-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **First posted** 2026-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Primary completion date** 2028-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Start date** 2026-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Size and sites **Participants** 4,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Planned participants** 4,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Number of sites** 325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Identifiers **Registry ID** NCT07667803 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **ClinicalTrials.gov ID** NCT07667803 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Outcomes ### Primary outcomes 1. Percent body weight loss Timeframe: 72 weeks Percent change from baseline to Week 72 in body weight ### Secondary outcomes 1. Absolute body weight loss Timeframe: 72 weeks Absolute change from baseline to Week 72 in body weight (kg) 2. Total body weight loss of at least 5%, 10%, and 15% Timeframe: 72 weeks \* Achieved ≥ 5% body weight loss from baseline at Week 72 \* Achieved ≥ 10% body weight loss from baseline at Week 72 \* Achieved ≥ 15% body weight loss from baseline at Week 72 3. Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline Timeframe: 72 weeks Percent change from baseline to Week 72 in body weight 4. Waist circumference reduction Timeframe: 72 weeks Absolute change from baseline to Week 72 in waist circumference (cm) 5. Glycemic control Timeframe: 72 weeks Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%) 6. Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline Timeframe: 72 weeks Achieved normoglycemia (HbA1c \\< 5.7% \\\[39 mmol/mol\\\]) at Week 72 7. Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline Timeframe: 72 weeks \* Achieved HbA1c \\< 7.0% (53 mmol/mol) at Week 72 \* Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72 8. Systolic blood pressure reduction Timeframe: 72 weeks Change from baseline to Week 72 in systolic blood pressure (mmHg) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Sites - Research SiteBirmingham, United StatesRecruiting - Research SiteDothan, United StatesRecruiting - Research SiteChandler, United StatesRecruiting - Research SiteSun City, United StatesNot yet recruiting - Research SiteLittle Rock, United StatesRecruiting - Research SiteLynwood, United StatesRecruiting - Research SiteRolling Hills Estates, United StatesRecruiting - Research SiteSacramento, United StatesRecruiting - Research SiteArvada, United StatesRecruiting - Research SiteNew Haven, United StatesNot yet recruiting - Research SitePlantation, United StatesNot yet recruiting - Research SiteTampa, United StatesRecruiting - Research SiteWoodstock, United StatesRecruiting - Research SiteAmmon, United StatesRecruiting - Research SiteMelrose Park, United StatesRecruiting - Research SiteIndianapolis, United StatesRecruiting - Research SiteWichita, United StatesRecruiting - Research SiteLouisville, United StatesRecruiting - Research SiteAlexandria, United StatesRecruiting - Research SiteBaltimore, United StatesNot yet recruiting - Research SitePotomac, United StatesRecruiting - Research SiteWhite Marsh, United StatesRecruiting - Research SiteYpsilanti, United StatesWithdrawn - Research SiteRidgeland, United StatesRecruiting - Research SiteKansas City, United StatesRecruiting And 300 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## References ### Other registry identifiers (2) - 2025 - 2025-524688-19 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07667803) ## Related records ### Drugs (1) - [Elecoglipron](https://trialight.com/data/asset/elecoglipron-8e9246dc-f27c-5602-b7aa-f57855d22924.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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