NCT02730169 is a Phase 2 clinical trial of BGS649 in Hypogonadotropic Hypogonadism, sponsored by Mereo BioPharma.

Who is sponsoring NCT02730169?

NCT02730169 is sponsored by Mereo BioPharma.

What drugs are being tested in NCT02730169?

Interventions in NCT02730169: BGS649, Placebo.

What condition does NCT02730169 study?

NCT02730169 studies Hypogonadotropic Hypogonadism.

Is NCT02730169 still recruiting?

NCT02730169 is currently completed. Last updated 14 September 2022.

Are results published for NCT02730169?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-14 · How we verify

NCT02730169

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

Completed Phase 2 Results posted Last updated 14 September 2022

What this trial tests

Phase 2 trial testing BGS649 in Hypogonadotropic Hypogonadism in 271 participants. Completed in 19 May 2018.

Timeline

12 May 2016

Primary endpoint
15 February 2018

19 May 2018

Quick facts

Lead sponsor	Mereo BioPharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	271
Start date	12 May 2016
Primary completion	15 February 2018
Estimated completion	19 May 2018
Sites	63 locations across Italy, United Kingdom, United States, Spain

Drugs / interventions tested

BGS649 — full drug profile →
Placebo

Conditions studied

Hypogonadotropic Hypogonadism — all drugs for Hypogonadotropic Hypogonadism →

Sponsor

Mereo BioPharma — full company profile →

Who can join

Adults 18 to 65, male only, with Hypogonadotropic Hypogonadism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment Primary · 24 weeks of treatment

Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.

Group	Value	95% CI
BGS649 0.1 mg	59
BGS649 0.3 mg	62
BGS649 1.0 mg	63
Placebo	7

The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Secondary · Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \>1000 ng/dL were considered super-physiological outside the normal range.

Baseline

Group	Value	95% CI
BGS649 0.1 mg	7
BGS649 0.3 mg	12
BGS649 1.0 mg	11
Placebo	7

Visit 2 (Day 8)

Group	Value	95% CI
BGS649 0.1 mg	54
BGS649 0.3 mg	53
BGS649 1.0 mg	57
Placebo	7

Visit 3 (Week 4)

Group	Value	95% CI
BGS649 0.1 mg	63
BGS649 0.3 mg	62
BGS649 1.0 mg	64
Placebo	10

Visit 4 (Week 8)

Group	Value	95% CI
BGS649 0.1 mg	63
BGS649 0.3 mg	61
BGS649 1.0 mg	65
Placebo	11

Visit 5 (Week 12)

Group	Value	95% CI
BGS649 0.1 mg	58
BGS649 0.3 mg	62
BGS649 1.0 mg	64
Placebo	7

Visit 6 (Week 16)

Group	Value	95% CI
BGS649 0.1 mg	57
BGS649 0.3 mg	63
BGS649 1.0 mg	63
Placebo	8

Visit 7 (Week 20)

Group	Value	95% CI
BGS649 0.1 mg	57
BGS649 0.3 mg	63
BGS649 1.0 mg	66
Placebo	9

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	59
BGS649 0.3 mg	62
BGS649 1.0 mg	63
Placebo	7

Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Secondary · Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.

Baseline

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	0
Placebo	0

Visit 2 (Day 8)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	0
Placebo	0

Visit 3 (Week 4)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	0
Placebo	0

Visit 4 (Week 8)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	1
Placebo	0

Visit 5 (Week 12)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	2
Placebo	2

Visit 6 (Week 16)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	2
Placebo	1

Visit 7 (Week 20)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	0
Placebo	1

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	0
BGS649 0.3 mg	0
BGS649 1.0 mg	1
Placebo	0

Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment. Secondary · 24 weeks of treatment

Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \>1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.

Group	Value	95% CI
BGS649 0.1 mg	59
BGS649 0.3 mg	62
BGS649 1.0 mg	63
Placebo	7

Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Secondary · Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.

Visit 2 (Day 8)

Group	Value	95% CI
BGS649 0.1 mg	1.680	± 1.7503
BGS649 0.3 mg	2.095	± 1.3719
BGS649 1.0 mg	3.309	± 1.8200
Placebo	-0.183	± 1.3531

Visit 3 (Week 4)

Group	Value	95% CI
BGS649 0.1 mg	2.237	± 2.1982
BGS649 0.3 mg	3.626	± 2.6519
BGS649 1.0 mg	5.235	± 4.8684
Placebo	-0.385	± 1.2423

Visit 4 (Week 8)

Group	Value	95% CI
BGS649 0.1 mg	2.272	± 2.1908
BGS649 0.3 mg	3.653	± 3.0907
BGS649 1.0 mg	5.676	± 4.1471
Placebo	-0.169	± 1.5237

Visit 5 (Week 12)

Group	Value	95% CI
BGS649 0.1 mg	2.503	± 2.2230
BGS649 0.3 mg	3.511	± 3.7050
BGS649 1.0 mg	5.064	± 3.9739
Placebo	-0.341	± 1.4575

Visit 6 (Week 16)

Group	Value	95% CI
BGS649 0.1 mg	2.557	± 1.6964
BGS649 0.3 mg	3.704	± 3.6269
BGS649 1.0 mg	5.004	± 4.3397
Placebo	-0.395	± 1.4793

Visit 7 (Week 20)

Group	Value	95% CI
BGS649 0.1 mg	2.553	± 2.2380
BGS649 0.3 mg	3.653	± 3.7381
BGS649 1.0 mg	4.884	± 3.9297
Placebo	-0.193	± 1.3585

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	2.108	± 1.9892
BGS649 0.3 mg	3.560	± 3.6138
BGS649 1.0 mg	5.209	± 4.4894
Placebo	-0.043	± 1.5575

Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Secondary · Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.

Visit 2 (Day 8)

Group	Value	95% CI
BGS649 0.1 mg	3.553	± 2.2022
BGS649 0.3 mg	4.575	± 2.0756
BGS649 1.0 mg	5.307	± 2.8315
Placebo	-0.51	± 0.8273

Visit 3 (Week 4)

Group	Value	95% CI
BGS649 0.1 mg	4.158	± 2.1353
BGS649 0.3 mg	5.540	± 2.8344
BGS649 1.0 mg	6.551	± 4.2155
Placebo	-0.111	± 1.0638

Visit 4 (Week 8)

Group	Value	95% CI
BGS649 0.1 mg	4.318	± 2.4147
BGS649 0.3 mg	5.878	± 2.9916
BGS649 1.0 mg	7.620	± 4.7883
Placebo	0.047	± 1.2241

Visit 5 (Week 12)

Group	Value	95% CI
BGS649 0.1 mg	4.809	± 2.5582
BGS649 0.3 mg	5.768	± 3.2474
BGS649 1.0 mg	8.132	± 5.9526
Placebo	-0.075	± 1.0723

Visit 6 (Week 16)

Group	Value	95% CI
BGS649 0.1 mg	5.188	± 2.6876
BGS649 0.3 mg	6.350	± 3.4261
BGS649 1.0 mg	8.045	± 6.1773
Placebo	-0.165	± 1.1924

Visit 7 (Week 20)

Group	Value	95% CI
BGS649 0.1 mg	5.059	± 2.5714
BGS649 0.3 mg	6.073	± 3.5199
BGS649 1.0 mg	8.409	± 6.6502
Placebo	-0.030	± 1.0932

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	4.836	± 2.6901
BGS649 0.3 mg	6.183	± 3.4817
BGS649 1.0 mg	8.282	± 7.0523
Placebo	0.038	± 1.2164

Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. Secondary · Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment

Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.

Visit 5 (Week 12), Pre-Dose

Group	Value	95% CI
BGS649 0.1 mg	0.73	0.64 – 0.83
BGS649 0.3 mg	2.55	2.33 – 2.80
BGS649 1.0 mg	8.93	8.29 – 9.62

Visit 5 (Week 12), 1 hour Post-Dose

Group	Value	95% CI
BGS649 0.1 mg	1.43	1.24 – 1.65
BGS649 0.3 mg	4.39	3.89 – 4.97
BGS649 1.0 mg	14.91	13.52 – 16.45

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	0.85	0.72 – 1.00
BGS649 0.3 mg	2.97	2.20 – 4.00
BGS649 1.0 mg	10.04	8.23 – 12.25

Visit 8 (Week 24)/End of Treatment

Group	Value	95% CI
BGS649 0.1 mg	0.78	0.64 – 0.97
BGS649 0.3 mg	2.76	2.14 – 3.57
BGS649 1.0 mg	9.10	7.61 – 10.89

Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. Secondary · Week 24 and week 24/End of treatment

Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	0.51	0.43 – 0.61
BGS649 0.3 mg	1.95	1.60 – 2.38
BGS649 1.0 mg	5.81	4.63 – 7.28

Visit 8 (Week 24)/End of Treatment

Group	Value	95% CI
BGS649 0.1 mg	0.49	0.42 – 0.58
BGS649 0.3 mg	1.58	1.19 – 2.08
BGS649 1.0 mg	5.28	4.16 – 6.71

Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Secondary · Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.

Visit 2 (Day 8)

Group	Value	95% CI
BGS649 0.1 mg	0.045	± 0.1840
BGS649 0.3 mg	0.040	± 0.4830
BGS649 1.0 mg	0.011	± 0.4606
Placebo	0.015	± 0.2179

Visit 3 (Week 4)

Group	Value	95% CI
BGS649 0.1 mg	0.141	± 0.1742
BGS649 0.3 mg	0.082	± 0.5198
BGS649 1.0 mg	0.092	± 0.4338
Placebo	0.038	± 0.2700

Visit 4 (Week 8)

Group	Value	95% CI
BGS649 0.1 mg	0.166	± 0.2651
BGS649 0.3 mg	0.105	± 0.4747
BGS649 1.0 mg	0.132	± 0.3343
Placebo	0.055	± 0.4500

Visit 5 (Week 12)

Group	Value	95% CI
BGS649 0.1 mg	0.190	± 0.3895
BGS649 0.3 mg	0.271	± 0.9626
BGS649 1.0 mg	0.178	± 0.5405
Placebo	0.039	± 0.4382

Visit 6 (Week 16)

Group	Value	95% CI
BGS649 0.1 mg	0.147	± 0.2655
BGS649 0.3 mg	0.102	± 0.5500
BGS649 1.0 mg	0.160	± 0.4037
Placebo	0.016	± 0.2631

Visit 7 (Week 20)

Group	Value	95% CI
BGS649 0.1 mg	0.158	± 0.2913
BGS649 0.3 mg	0.480	± 2.6029
BGS649 1.0 mg	0.116	± 0.4560
Placebo	0.022	± 0.3942

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	0.218	± 0.4312
BGS649 0.3 mg	0.391	± 1.8627
BGS649 1.0 mg	0.085	± 0.2930
Placebo	0.067	± 0.4787

Mean (SD) Change From Baseline in Haematocrit to Week 24. Secondary · Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.

Visit 2 (Day 8)

Group	Value	95% CI
BGS649 0.1 mg	-0.0003	± 0.02279
BGS649 0.3 mg	0.0014	± 0.01945
BGS649 1.0 mg	-0.0016	± 0.03487
Placebo	-0.0029	± 0.02374

Visit 3 (Week 4)

Group	Value	95% CI
BGS649 0.1 mg	0.0036	± 0.01855
BGS649 0.3 mg	0.0024	± 0.02095
BGS649 1.0 mg	0.0067	± 0.02997
Placebo	-0.0024	± 0.02539

Visit 4 (Week 8)

Group	Value	95% CI
BGS649 0.1 mg	0.0151	± 0.02153
BGS649 0.3 mg	0.0162	± 0.02709
BGS649 1.0 mg	0.0258	± 0.03233
Placebo	-0.0041	± 0.02383

Visit 5 (Week 12)

Group	Value	95% CI
BGS649 0.1 mg	0.0153	± 0.02419
BGS649 0.3 mg	0.0175	± 0.02270
BGS649 1.0 mg	0.0256	± 0.02906
Placebo	-0.0082	± 0.02882

Visit 6 (Week 16)

Group	Value	95% CI
BGS649 0.1 mg	0.0142	± 0.02195
BGS649 0.3 mg	0.0233	± 0.02408
BGS649 1.0 mg	0.0229	± 0.03260
Placebo	-0.0079	± 0.02533

Visit 7 (Week 20)

Group	Value	95% CI
BGS649 0.1 mg	0.0195	± 0.02545
BGS649 0.3 mg	0.0192	± 0.02672
BGS649 1.0 mg	0.0187	± 0.03222
Placebo	-0.0063	± 0.03037

Visit 8 (Week 24)

Group	Value	95% CI
BGS649 0.1 mg	0.0171	± 0.02612
BGS649 0.3 mg	0.0159	± 0.02621
BGS649 1.0 mg	0.0216	± 0.02587
Placebo	-0.0032	± 0.02884

Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. Secondary · Screening to Week 24

Summary of DEXA Scan T-score at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. DEXA T-score was calculated based on actual measured bone density value and compared to a standard reference range for healthy young adult men. A bone density scan compares bone density with the bone density expected for a young healthy adult or a healthy adult of the same age, gender and ethnicity. The difference is calculated as a standard deviation (SD) score. The measures between the bone density and the expected value of a young healthy adult is known as the T score. The World Health Organizati

Hip

Group	Value	95% CI
BGS649 0.1 mg	0.01	± 0.382
BGS649 0.3 mg	0.05	± 0.315
BGS649 1.0 mg	-0.02	± 0.323
Placebo	0.01	± 0.266

Femoral neck

Group	Value	95% CI
BGS649 0.1 mg	-0.16	± 0.337
BGS649 0.3 mg	0.02	± 0.441
BGS649 1.0 mg	-0.11	± 0.392
Placebo	0.03	± 0.212

Lumber spine

Group	Value	95% CI
BGS649 0.1 mg	-0.12	± 0.279
BGS649 0.3 mg	-0.08	± 0.381
BGS649 1.0 mg	-0.22	± 0.351
Placebo	0.07	± 0.346

Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 Secondary · Screening to Week 24

Summary of DEXA scan density at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. Bone density was evaluated with standard procedure for Hologic and General Electric Lunar scanners.

Hip

Group	Value	95% CI
BGS649 0.1 mg	-0.0026	± 0.03990
BGS649 0.3 mg	-0.0020	± 0.03828
BGS649 1.0 mg	-0.0072	± 0.02724
Placebo	0.0005	± 0.03315

Femoral neck

Group	Value	95% CI
BGS649 0.1 mg	-0.0248	± 0.04583
BGS649 0.3 mg	-0.0044	± 0.06666
BGS649 1.0 mg	-0.0116	± 0.05139
Placebo	0.0028	± 0.02747

Lumber spine

Group	Value	95% CI
BGS649 0.1 mg	-0.0167	± 0.03174
BGS649 0.3 mg	-0.0177	± 0.05018
BGS649 1.0 mg	-0.0255	± 0.04044
Placebo	0.0100	± 0.04016

Adverse events — posted to ClinicalTrials.gov

Time frame: After randomisation and up to 90 days after the last administration of study drug.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BGS649 0.1 mg

Serious: 2/67 (3%)

Deaths: 0/67

BGS649 0.3 mg

Serious: 2/66 (3%)

Deaths: 0/66

BGS649 1.0 mg

Serious: 5/67 (7%)

Deaths: 0/67

Placebo

Serious: 5/71 (7%)

Deaths: 0/71

Serious adverse events (22 terms)

Reaction	System	BGS649 0.1 mg	BGS649 0.3 mg	BGS649 1.0 mg	Placebo
Postoperative wound infection	Infections and infestations	—	—	—	—
Arthritis infective	Infections and infestations	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Chest pain	General disorders	—	—	—	—
Multiple organ dysfunction syndrome	General disorders	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Gouty arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Intestinal perforation	Gastrointestinal disorders	—	—	—	—
Skull fracture	Injury, poisoning and procedural complications	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Diabetic foot	Skin and subcutaneous tissue disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Other adverse events (201 terms — click to expand)

Reaction	System	BGS649 0.1 mg	BGS649 0.3 mg	BGS649 1.0 mg	Placebo
Headache	Nervous system disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Haematocrit increased	Investigations	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Prostatic specific antigen increased	Investigations	—	—	—	—
Fatigue	General disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Polycythaemia	Blood and lymphatic system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Blood triglycerides increased	Investigations	—	—	—	—
Weight increased	Investigations	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Osteopenia	Musculoskeletal and connective tissue disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—
Vitamin D deficiency	Metabolism and nutrition disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Gynaecomastia	Reproductive system and breast disorders	—	—	—	—
Dry eye	Eye disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Tooth abscess	Infections and infestations	—	—	—	—
Tooth infection	Infections and infestations	—	—	—	—
Bacterial prostatitis	Infections and infestations	—	—	—	—

Most-reported serious reactions: Postoperative wound infection, Arthritis infective, Diverticulitis, Osteomyelitis, Pneumonia, Pyelonephritis, Sepsis, Chest pain.

Data from ClinicalTrials.gov NCT02730169 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Leflutrozole in male obesity-associated hypogonadotropic hypogonadism: Ph 2b double-blind randomised controlled trial.
Jones TH, Dobs AS, Randeva H, Moore W, et al · · 2023 · cited 10× · PMID 37579053 · DOI 10.1093/ejendo/lvad099
OR18-4 Beneficial Effect on Sperm Production of Leflutrozole in Men with Obesity-Associated Secondary Hypogonadotropic Hypogonadism: Results from a Phase II Study
Jones T, Dobs A, MacKinnon A, Parkin J. · · 2019

Verify or expand the search:

Other trials of BGS649

Trials testing the same drug.

NCT02908074 — A 6 Month Safety Extension Study of MBGS205 · Phase 2 · completed

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Currently open trials in the same condition.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02730169 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mereo BioPharma
Last refreshed: 14 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02730169.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02730169

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (22 terms)

Sponsor's own description

Publications & conference data

Related trials

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Other Mereo BioPharma trials

Verify against primary sources