Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609768716927 Date of Registration: 11/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase III study to investigate the efficacy and safety of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus
Official scientific title A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination with Dapagliflozin Compared with Placebo in Adults with Type 2 Diabetes Mellitus (Eluminate-1)
Brief summary describing the background and objectives of the trial Type 2 Diabetes Mellitus (T2DM) is a complex, multifactorial metabolic disease influenced by genetic, behavioral, and environmental factors. Its global prevalence continues to rise in both adults and children, and T2DM accounts for more than 90% of all diabetes cases worldwide. An estimated 589 million adults (11.1%) are currently living with diabetes, a figure projected to reach 853 million (13%) by 2050. Contemporary treatment guidelines prioritize therapies with benefits beyond HbA1c reduction. In particular, GLP‑1 receptor agonists (GLP‑1 RAs) and SGLT2 inhibitors (SGLT2i) are recommended for individuals at high cardiovascular or renal risk, irrespective of baseline HbA1c. Weight loss is also an important consideration when initiating first‑line therapy for T2DM. Despite their proven glycemic, cardiovascular, and renal benefits, most approved GLP‑1 RAs require daily or weekly subcutaneous injection. The only currently approved oral GLP‑1 RA has strict administration requirements, including fasting and timing constraints relative to food, water, and other medications. Given the projected increase in T2DM prevalence and the high coexistence of overweight/obesity among people with T2DM, there is a clear need for next‑generation therapies that combine effective glycemic control with clinically meaningful weight reduction. Ideally, such therapies should be easy to initiate and use, rapidly distributable, and free from requirements for refrigeration, injection devices, or stringent fasting. The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with T2DM. The study duration will be up to 46 weeks (excluding the optional pre-screening), including: • Screening period: up to 28 days • Treatment period: 40 weeks• • Safety follow-up period: 14 days after the last treatment visit (or EDV) The visit frequency will be every 28 days up to Week 24, followed
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Eluminate1
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 29/09/2026
Actual trial start date
Anticipated date of last follow up 27/07/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
DOH-27-082026-7684 SANCTR
D7261C00002 AstraZeneca AB
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Elecoglipron 45mg 40 weeks Participants who are eligible according to the inclusion and exclusion criteria will be randomly assigned in a 1:1:1:1 ratio to receive one of the following treatments: • Elecoglipron 45 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin 10 mg, once daily • Elecoglipron-matched placebo + dapagliflozin-matched placebo, once daily 18
Experimental Group Elecoglipron 65mg 40 weeks Participants who are eligible according to the inclusion and exclusion criteria will be randomly assigned in a 1:1:1:1 ratio to receive one of the following treatments: • Elecoglipron 45 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin 10 mg, once daily • Elecoglipron-matched placebo + dapagliflozin-matched placebo, once daily 18
Experimental Group Elecoglipron and Dapagliflozin 65mg + 10mg 40 weeks Participants who are eligible according to the inclusion and exclusion criteria will be randomly assigned in a 1:1:1:1 ratio to receive one of the following treatments: • Elecoglipron 45 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin 10 mg, once daily • Elecoglipron-matched placebo + dapagliflozin-matched placebo, once daily 18
Control Group Placebo 40 weeks Participants who are eligible according to the inclusion and exclusion criteria will be randomly assigned in a 1:1:1:1 ratio to receive one of the following treatments: • Elecoglipron 45 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin-matched placebo, once daily • Elecoglipron 65 mg + dapagliflozin 10 mg, once daily • Elecoglipron-matched placebo + dapagliflozin-matched placebo, once daily 16 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants are eligible to be included in the study only if all of the following criteria apply: Age 1 Participant must be ≥ 18 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2 Participants with a diagnosis of T2DM as per World Health Organization or local diagnostic standards for at least 90 days prior to the Screening Visit (Visit 1). 3 T2DM inadequately managed with lifestyle management alone (ie, treatment-naïve or on no current glucose lowering agents) or a stable dose of metformin as judged by the Investigator for at least 90 days before the Screening Visit (Visit 1) and through the screening period. 4 HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) as determined by the central laboratory at the Screening Visit (Visit 1). Weight 5 BMI of ≥ 23 kg/m2 at the Screening Visit (Visit 1). 6 Stable body weight (self-reported or documented) for 90 days prior to the Screening Visit (Visit 1) (± 5% body weight change) and through the screening period as determined by the Investigator. Sex and Contraceptive/Barrier Requirements 7 Male and/or female assigned at birth, inclusive of all gender identities. Definitions for WOCBP and females of nonchildbearing potential and contraception recommendations for females and males are included in Appendix F, with further details on restricted contraception in Section 6.9.2.1. Informed Consent 8 Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 9 Provision of signed and dated written ICF before any mandatory study-specific procedures, sampling, or analysis. Participants are excluded from the study if any of the following criteria apply: Diabetes 1 Any of the following medical history or complications related to: (a) T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma within 180 days prior to the Screening Visit (Visit 1) or during the screening period. (b) Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema. Fundus photography or dilated fundoscopic exam will be performed as per the SoA (Section 1.3) by an ophthalmologist/optometrist or according to local practice to confirm eligibility. (c) Have had more than one episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 180 days prior to the Screening Visit (Visit 1) or during the screening period, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as per Investigator judgment. Weight 2 Any of the following that are related to medical reasons or planned/previous changes in weight (see further details in Section 5.3.5 and Appendix G): (a) Received any prescription or non-prescription medication or herbal supplements for weight loss within the last 90 days prior to the Screening Visit (Visit 1) and through the screening period. (b) Previous or planned (within study period) endoscopic or surgical weight loss procedures (eg, bariatric surgery or fitting of a weight loss device [eg, gastric balloon or duodenal barrier]). Exception: participants with fitted weight loss devices removed for more than 180 days prior to the Screening Visit (Visit 1) and stable body weight (as noted in Inclusion Criterion 6). (c) Planned to start a targeted weight loss program during the study other than lifestyle management considerations outlined in the protocol. Gastrointestinal/Liver 3 Have a known clinically significant condition affe Adult: 18 Year(s)-44 Year(s) 18 Year(s) 105 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2026 Pharma Ethics Independent Research Committee
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road, Lyttleton Manor, Centurion Pretoria 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/07/2026 SAHPRA
Ethics Committee Address
Street address City Postal code Country
CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria Pretoria 0083 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for glycemic control Baseline to Week 40 in HbA1c
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 45 mg + dapagliflozin 10 mg compared with placebo for glycemic control Baseline to Week 40
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 45 mg + dapagliflozin 10 mg compared with placebo for body weight reduction Baseline to Week 40 in body weight
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 45 mg + dapagliflozin 10 mg compared with placebo for Systolic Blood Pressure reduction Baseline to Week 40 in SBP
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for body weight reduction Baseline to Week 40
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for lipid parameter improvement Baseline to Week 40
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for Diastolic Blood Pressure reduction Baseline to Week 40 in DBP
Secondary Outcome To evaluate the efficacy of elecoglipron 45 mg, elecoglipron 65 mg, and elecoglipron 65 mg + dapagliflozin 10 mg compared with placebo for rescue medication Time to initiation of rescue medication over 40 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aliwal Shoal Medical 14 Bisset street, Umkomaas, Durban, 4170 Durban 4170 South Africa
Langeberg Clinical Trials Langeberg Medical Centre, Cnr Brighton and Kipling Roads Kraaifontein Cape Town 7570 South Africa
Synopsis Research 3rd Floor, Suite 303, Library Square, Wilderness Road, Claremont Cape Town 7708 South Africa
Steve Biko Hospital Clinical Research Unit, University of Pretoria, Room 2-54 Pathology Building, Prinshof Medical Campus, Dr. Savage Road Pretoria 0002 South Africa
Dr Naeem Moosa Practice Nirvana Drive, Shop 6, Extension 8 Freeway Plaza, Lenasia Johannesburg 1827 South Africa
Dr K Gounden Practice Suite 1-2 Wingen centre, 7 Wingen Walk, Shallcross Durban 4093 South Africa
Dr Deen Pillay Practice 26 Daffodil Street, Stanger Manor, Kwadukuza Durban 4449 South Africa
Dr T Govender Practice Unit 2 Oryx Park, 4 Teejay Close, Everite Industria, Brackenfell Cape Town 7560 South Africa
Paarl Research Centre 22 Verster Street, Lemoenkloof, Paarl Cape Town 7646 South Africa
TREAD Research Room 41, 8th Floor, Department of Cardiology, Tygerberg Hospital, Francie van Zijl Avenue, Parow Cape Town 7500 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
AstraZeneca AB s-151 85 Sodertalje Sweden
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AstraZeneca AB s-151 85 Sodertalje Sweden Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Julien Trokis trokisjs@gmail.com 0219871690 Langeberg Clinical Trials, Langeberg Medical Centre, Cnr Brighton and Kipling Roads, Kraaifontein
City Postal code Country Position/Affiliation
Cape Town 7570 South Africa National Principal Investigator
Role Name Email Phone Street address
Public Enquiries Fatima Cassim fatima.cassim@astrazeneca.com 0117976154 Building 2 Northdowns Office Park, 17 Georgian Crescent West, Bryanston
City Postal code Country Position/Affiliation
Johannesburg 2191 South Africa Country Head
Role Name Email Phone Street address
Scientific Enquiries Fatima Cassim fatima.cassim@astrazeneca.com 0117976154 Building 2 Northdowns Office Park, 17 Georgian Crescent West, Bryanston
City Postal code Country Position/Affiliation
Johannesburg 2191 South Africa Country Head
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The CSP has been subject to a peer review according to AstraZeneca Standard procedures. The CSP is publicly registered and the results are disclosed and/or published according to the AstraZeneca Global Policy on Bioethics and in compliance with prevailing laws and regulations. The clinical trial data at the individual level will be made available to researchers who were not part of the original study team within 12 months of study completion. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be done within 12 months of the study completion date. TBC
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information