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.: PACTR202607641626021 Date of Registration: 16/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title NN9838-7910: A research study to look at how two different doses of CagriSema and one dose of semaglutide help people living with obesity with or without type 2 diabetes lose weight
Official scientific title A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes
Brief summary describing the background and objectives of the trial This master protocol includes two individual sub-studies. Each sub-study is an interventional, multi-national, multi-centre, randomised, double-blind, active-comparator, 83-week study. Participants will be randomised in a 2:2:1 ratio to CagriSema 2.4 mg/7.2 mg, CagriSema 2.4 mg/2.4 mg, or semaglutide 7.2 mg. Sub-study 1 will include 1250 participants with obesity without T2D, and Sub-study 2 will include 1250 participants with obesity and T2D. Each treatment includes a 20-week dose-escalation period, treatment is initiated at either 1) CagriSema 0.25 mg/0.25 mg, 2) CagriSema 0.25 mg/0.25 mg, or 3) semaglutide 0.25 mg once weekly for four weeks followed by stepwise dose escalations every four weeks up to 1) 2.4 mg/7.2 mg, 2) 2.4 mg/2.4 mg, or 3) 7.2 mg. Primary objective: 1. To confirm superiority on body weight reduction of CagriSema s.c. 2.4 mg/7.2 mg versus CagriSema s.c. 2.4 mg/2.4 mg and semaglutide s.c. 7.2 mg once weekly as adjunct to reduced-calorie diet and increased physical activity 2. To confirm superiority on change in systolic blood pressure of CagriSema s.c. 2.4 mg/7.2 mg versus semaglutide s.c. 7.2 mg
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 03/08/2026
Actual trial start date
Anticipated date of last follow up 20/04/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
DOH-27-072026-5496 SANCTR
NN9838-7910 Novo Nordisk
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CagriSema 2.4 mg 7.2 mg Treatment will be initiated at 0.25 mg/0.25 mg and participants will then be dose-escalated every four weeks until they reach their assigned dose. 0.25 mg/0.25 mg for four weeks, 0.5 mg/0.5 mg for four weeks, 1.0 mg/1.0 mg for four weeks, 1.7 mg/1.7 mg for four weeks and 2.4 mg/2.4 mg for four weeks 2.4 mg/7.2 mg up to 52 weeks Dose is once-weekly 20-week double-blind dose-escalation period, a 52-week double-blind maintenance period and an 8-week off treatment follow-up period Subcutaneous 40
Control Group CagriSema 2.4 mg 2.4 mg Treatment will be initiated at 0.25 mg/0.25 mg and participants will then be dose-escalated every four weeks until they reach their assigned dose. 0.25 mg/0.25 mg for four weeks, 0.5 mg/0.5 mg for four weeks, 1.0 mg/1.0 mg for four weeks and 1.7 mg/1.7 mg for four weeks 2.4 mg/2.4 mg up to 52 weeks Dose is once-weekly 20-week double-blind dose-escalation period, a 52-week double-blind maintenance period and an 8-week off treatment follow-up period Subcutaneous 40 Dose Comparison
Control Group Semaglutide 7.2 mg Treatment will be initiated at 0.25 mg and participants will then be dose-escalated every four weeks until they reach their assigned dose. Placebo cagrilintide/semaglutide 0 mg/0.25 mg for four weeks, 0 mg/0.5 mg for four weeks, 0 mg/1.0 mg for four weeks, 0 mg/1.7 mg for four weeks and 0 mg/2.4 mg for four weeks Placebo cagrilintide/semaglutide 0 mg/7.2 mg for up to 52 weeks Dose is once-weekly 20-week double-blind dose-escalation period, a 52-week double-blind maintenance period and an 8-week off treatment follow-up period Subcutaneous 40 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Key inclusion criteria: • Male or female (sex assigned at birth, inclusive of all gender identities). • Age 18 years or above at the time of signing the informed consent. • Body Mass Index (BMI) ≥ 35.0 kg/m2. • Participants without T2D (Sub-study 1): No history of T2D and glycated haemoglobin (HbA1c) < 6.5% (48 mmol/mol) Participants with T2D (Sub-study 2): A history of T2D and glycated haemoglobin (HbA1c) < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised. Key exclusion criteria: • A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records. • Use of any glucagon like peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 09/06/2026 SAHPRA
Ethics Committee Address
Street address City Postal code Country
Building A, Loftus Park, 416 Kirkness Street, Arcadia, Pretoria Pretoria 0083 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 30/06/2026 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amcor Road, Lyttelton Manor, 0157 Lyttelton Manor 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 29/06/2026 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
31 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Relative change in body weight (CagriSema s.c. 2.4 mg/7.2 mg versus CagriSema s.c. 2.4 mg/2.4 mg) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Relative change in body weight (CagriSema s.c. 2.4 mg/7.2 mg versus semaglutide s.c. 7.2 mg) (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Change in BMI From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of =30% weight reduction (Sub-study 1 only) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of =25% weight reduction (Sub-study 1 only) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of =20% weight reduction (Sub-study 2 only) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Change in waist circumference From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Change in systolic blood pressure From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Mean change in body weight From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of =20% weight reduction (only Sub-study 1) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of BMI < 30 kg/m2 From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of BMI < 27 kg/m2 From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of normal BMI (18.5 = BMI < 25) At end of treatment (week 72) week 72
Secondary Outcome Achievement of waist-to-height ratio of < 0.53 At end of treatment (week 72) week 72
Secondary Outcome Change in SBP From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Ratio to baseline • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Free fatty acids • Non-HDL cholesterol From baseline (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Change in SF-36v2 physical Function From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Change in IWQOL-Lite-CT physical function From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Change in HbA1c From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Achievement of HbA1c < 6.5% (only Sub-study 2) At end of treatment (week 72) week 72
Secondary Outcome Achievement of normal HbA1c < 5.7% At end of treatment (week 72) week 72
Secondary Outcome Number of TEAEs From randomisation (week 0) to end of study (week 80) Week 0 to week 80
Secondary Outcome Number of TESAEs From randomisation (week 0) to end of study (week 80) Week 0 to week 80
Secondary Outcome Ratio to baseline in inflammatory biomarkers: hsCRP and Il-6 From baseline (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Ratio to baseline in apolipoproteins (A1, B and CIII) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Reduction in anti-lipid medication From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Reduction in anti-hypertensive medication From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
Secondary Outcome Reduction in anti-diabetic medication (only sub-study 2) From randomisation (week 0) to end of treatment (week 72) Week 0 to week 72
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr D. Pillay Practice 26 Daffodil Street, Stanger Manor Kwadukuza 4449 South Africa
Dr Q.E. Bhorat Soweto Clinical Trials Centre House 1900, Sycamore Street, Dlamini Extension 2 Soweto 1818 South Africa
Dr Z. Bayat Lenasia Clinical Trial Centre K43 Highway, Marlin Avenue, Ext 8, Lenasia Johannesburg 1827 South Africa
Dr K. Coetzee Paarl Research Centre Medicross Building, 22 Verster Street, Lemoenkloof, Paarl Cape Town 7646 South Africa
Dr M.A. Fulat Clinical Trial Systems East Park Shopping Centre, Shop 18, First Floor, Baviaanspoort Road, East Lynne Pretoria 0186 South Africa
Dr F. Sirkhotte Newtown Clinical Research Centre First Floor Newgate Centre, 104 Rahima Moosa Street, Newtown Johannesburg 2001 South Africa
Dr A.E. Badat Wits Clinical Research Chris Hani Baragwanath Hospital, Chris Hani Road Soweto 2013 South Africa
Dr H. Makan Practice 46 Protea Avenue, Extension 3 Lenasia 1827 South Africa
Dr Z.E. Punt PHOENIX Pharma 2 Eastbourne Road, Mt Croix Port Elizabeth 6001 South Africa
Dr E. Snyman Eden Heart Research 9 Ryk Tulbach Str, Da Nova, Mossel Bay, 6500 Mossel Bay 6500 South Africa
Dr D.T. Khutsoane Suite 510, Parfitt Avenue, Bloemfotein Mediclinic, Bloemfontein, 9301 Bloemfontein 9301 South Africa
Dr N. Fourie IATROS International 20 Captain Proctor Street, Brandwag, Bloemfontein, 9301 Bloemfontein 9301 South Africa
Dr S. Coetzer Clinical Trials Network Helderberg 7 Arun Place, Sir Lowry Pass Road, Somerset West, 7130 Somerset West 7130 South Africa
Dr S. Chohan Sandton Medical Research Centre Wellness on Alon, 49 East Road, Morningside Manor, Sandton, 2196 Sandton 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Novo Nordisk Novo Nordisk, Novo Alle, 2880 Bagsvaerd, Denmark Bagsvaerd 2880 Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Novo Nordisk Novo Nordisk, Novo Alle, 2880, Bagsvaerd, Denmark Bagsvaerd 2880 Denmark Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Essack Mitha emitha@newtowncrc.co.za 0823223402 Newtown Clinical Research Centre, First Floor Newgate Centre, 104 Rahima Moosa Street, Newtown
City Postal code Country Position/Affiliation
Johannesburg 2001 South Africa National Principal Investigator
Role Name Email Phone Street address
Public Enquiries Darren Katzman drkz@novonordisk.com 0112020500 Novo Nordisk Pty Ltd, 90 Grayston Drive, Sandown, Sandton, Johannesburg, 2196
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Director Clinical Medical and Regulatory
Role Name Email Phone Street address
Scientific Enquiries Wendy Green Green Thompson wngt@novonordisk.com 0112020500 Novo Nordisk Pty Ltd, 90 Grayston Dr, Sandown, Sandton, 2196
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Director Clinical Development Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Novo Nordisk is committed to sharing information about all clinical studies and their results, irrespective if these are positive or negative. Access to study information is available for researchers, participants in the study and anyone else who may be interested. Information about all clinical studies is posted in publicly accessible clinical study registries to inform about ongoing and completed trials. The studies are documented in national registries, and the US registry ClinicalTrials.gov which is open to the public as not all national registries are publicly accessible. When a study includes at least one study site in the European Economic Area, clinical trial applications for these studies are submitted to the EudraCT, and the information from submissions related to phase 2-3 in adults and phase 1-4 in children is made publicly available via the EU CTR. When the study has ended, the aim is to publish the key conclusions in scientific journals. Novo Nordisk strives to submit clinical trials results no more than 12-18 months after study completion. The results are communicated further by including them in applicable registries and within the proper timeframes as required by current laws and regulations. Results are also available on the Novo Nordisk clinical trials website in the form of summaries in layperson language and clinical study reports are posted within 30 days of new medicine or indication approval in both the US and EU, and results from studies completed after approval are posted within 12 months of study completion. In addition, researchers can request access to detailed clinical study data, which they can explore for their own research purposes. All information communicated and shared on clinical studies is de-identified to ensure the trust and safety of participants in the clinical study. Clinical study documents, such as clinical study reports, synopses, and protocols posted to public websites, are first ‘redacted’. Clinical Study Report The date of the clinical trial report will be on 03 Aug 2028 and the data will be published on the relevant clinical disclosure website (e.g. clinicaltrial.gov) within 1 year after LPLV. When the data is published on the disclosure website, it is open to public. But all the data is anonymous without personal identifying information.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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