GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity

Lead sponsor

Novo Nordisk A/S

Assets

NNC0165-1875 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

120

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-45

Primary endpoints

•Treatment-emergent AEs (any)•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04969939

Org study IDNN9775-4708

Secondary IDU1111-1254-9046WHO

Timeline

Milestones

Study start2021-07-15actual

Study first posted2021-07-21actual

Primary completion2022-12-06actual

Study completion2023-01-30actual

Last update posted2026-01-08actual

Results first posted2026-01-08actual

Assets

Investigational agents

NNC0165-1875 Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

•Male or female, age above or equal to 18 years at the time of signing informed consent.

•BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.

Exclusion criteria

•HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.

–History of type 1 or type 2 diabetes mellitus.

–Treatment with glucose-lowering agent(s) within 90 days before screening.

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

6 endpoints

Primary/registry result

Part 2b: Percentage Change in Body Weight

Time frame:Part 2: Randomisation (week 32), end of treatment (week 48)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change in body weight	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	-5.55	—
Part 2b: Placebo + Semaglutide 2.4 mg	-3.06	—

Treatment difference (%-point)-2.1595% CI-4.24 – -0.06p0.0437ANCOVA

Week 48 responses were analysed using an analysis of covariance model with randomised treatment as factors and baseline body weight (kg) as covariate.

Primary/protocol endpoint

Part 2b: Percentage Change in Body Weight

Time frame:Part 2: Randomisation (week 32), end of treatment (week 48)

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Part 2b: Change in Body Weight (kg)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms (kg)	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	-4.54	—
Part 2b: Placebo + Semaglutide 2.4 mg	-2.23	—

Secondary/registry result

Part 2b: Change in Waist Circumference

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	-4.80	—
Part 2b: Placebo + Semaglutide 2.4 mg	-2.69	—

Secondary/protocol endpoint

Part 2b: Change in Body Weight (kg)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Part 2b: Change in Waist Circumference

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Part 2b: Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage point of HbA1c	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	-0.17	—
Part 2b: Placebo + Semaglutide 2.4 mg	-0.17	—

Secondary/registry result

Part 2b: Change in Fasting Plasma Glucose (FPG)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/l	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	0.08	—
Part 2b: Placebo + Semaglutide 2.4 mg	-0.02	—

Secondary/registry result

Part 2b: Change in Fasting Insulin

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

change from baseline, improvement

Posted result

Group	Value (mean), pmol/l	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	-14.10	—
Part 2b: Placebo + Semaglutide 2.4 mg	-8.10	—

Secondary/protocol endpoint

Part 2b: Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Part 2b: Change in Fasting Plasma Glucose (FPG)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Part 2b: Change in Fasting Insulin

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints

Secondary/registry result

Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (mean), Ratio of total cholesterol	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	1.00	—
Part 2b: Placebo + Semaglutide 2.4 mg	1.07	—

Secondary/registry result

Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (mean), Ratio of HDL cholesterol	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	1.02	—
Part 2b: Placebo + Semaglutide 2.4 mg	1.08	—

Secondary/registry result

Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (mean), Ratio of LDL cholesterol	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	1.01	—
Part 2b: Placebo + Semaglutide 2.4 mg	1.08	—

Secondary/registry result

Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

VLDL, change

ratio, improvement

Posted result

Group	Value (mean), Ratio of VLDL cholesterol	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	0.96	—
Part 2b: Placebo + Semaglutide 2.4 mg	1.04	—

Secondary/registry result

Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (mean), Ratio of triglycerides	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	0.96	—
Part 2b: Placebo + Semaglutide 2.4 mg	1.03	—

Secondary/registry result

Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (mean), Ratio of free fatty acids	95% CI
Part 2b: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	0.87	—
Part 2b: Placebo + Semaglutide 2.4 mg	1.07	—

Secondary/protocol endpoint

Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)

Time frame:Part 2b: Randomisation (week 32), end of treatment (week 48)

Free fatty acids, change

ratio, improvement

Safety / tolerability / PK

6 endpoints

Primary/registry result

Part 1: Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Part 1: From time of dosing (day 1) to follow-up (week 24)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	56	—
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg	71	—
Part 1: Placebo + Semaglutide 2.4 mg	37	—

Primary/protocol endpoint

Part 1: Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Part 1: From time of dosing (day 1) to follow-up (week 24)

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)

Time frame:From randomisation (week 32) to end of the trial (week 56)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	220	—
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg	45	—
Part 2b: Placebo + Semaglutide 2.4 mg	56	—

Secondary/registry result

Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)

Time frame:From randomisation (week 32) to end of the trial (week 56)

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg	2	—
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg	0	—
Part 2b: Placebo + Semaglutide 2.4 mg	0	—

Secondary/protocol endpoint

Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)

Time frame:From randomisation (week 32) to end of the trial (week 56)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)

Time frame:From randomisation (week 32) to end of the trial (week 56)

Serious AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.